Method and apparatus for testing for color vision loss

ABSTRACT

A method for administering a cone contrast color vision test includes displaying a first color at a first contrast level in a first region of a display and a second color at a first contrast level in a second region of the display, receiving a first input signal via an input device that indicates whether the patient recognizes the first region, displaying the first color at a second contrast level in a third region of the display and the second color at a second contrast level in a fourth region of the display, receiving a second input signal indicative of whether the patient recognizes the third region, assigning a score related to cone sensitivity of the first color at the first and second contrast levels, storing the score, and comparing the score to a previous score to calculate a progression of a cone sensitivity loss.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit, under Articles 4 and 8 of theStockholm Act of the Paris Convention for the Protection of IndustrialProperty, and priority to U.S. patent application Ser. No. 17/068,417,filed Oct. 12, 2020, which application is a continuation-in-partapplication filed under 35 U.S.C. §§ 111(a) and 120 of U.S. patentapplication Ser. No. 15/888,553, filed Feb. 5, 2018, which applicationis a continuation-in-part application of U.S. patent application Ser.No. 14/819,046, filed on Aug. 5, 2015, which application is acontinuation of U.S. Nonprovisional patent application Ser. No.14/251,286, filed Apr. 11, 2014, which is a continuation of U.S.Nonprovisional patent application Ser. No. 13/887,272, filed May 3,2013, which claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Patent Application No. 61/642,378, filed May 3, 2012 andU.S. Provisional Patent Application No. 61/642,292, filed May 3, 2012.This application also claims the benefit, under articles 4 and 8 of theStockholm Act of the parties Convention for the Protection of IndustrialProperty, and priority to U.S. Pat. App. No. 63/262,416, filed Oct. 12,2021. Each of the above-identified applications are incorporated hereinby reference in their entireties.

FIELD

The present method and apparatus relate to eye tests for hereditary andacquired color vision loss and may be used for the early detection,progression and treatment monitoring of eye conditions including retinaldiseases, glaucoma, neurological diseases, TBI and concussion, as wellas retinal toxicity due to high-risk medications. Particularly, thesystems and methods disclosed herein use a Cone Contrast Test (CCT) toidentify hereditary color deficiency and acquired color vision lossassociated with early disease/damage/toxicity to (a) alert for earlydisease/damage/toxicity and (b) monitor progression and treatment ofsuch disease/damage/toxicity in an effort to (i) provide opportunity forearlier treatment, and (ii) prevent permanent eye damage.

BACKGROUND

The human eye sees color as a result of three types of receptors, calledcones, listed in the chart below. A range of wavelengths of lightstimulates each of these receptor types to varying degrees.Yellowish-green light, for example, stimulates both L and M conesequally strongly, but only stimulates S-cones weakly; red lightstimulates L cones much more than M cones, and S cones hardly at all;blue-green light stimulates M cones more than L cones, and S cones a bitmore strongly; and blue light stimulates S cones more strongly than redor green light, but L and M cones more weakly. The brain combines theinformation from each type of photoreceptor to give rise to differentperceptions (i.e., colors) of different wavelengths of light.

Cone type Name Range Peak wavelength S B 400-500 nm 420-440 nm M Γ450-630 nm 534-555 nm L P 500-700 nm 564-580 nm

Test procedures such as optical computed tomography (OCT), visual fieldanalyzers, etc., are used primarily to screen and diagnose specific eyedisease. OCTs and visual field analyzers are tests generally used oncethe patient is symptomatic, well after permanent eye damage hasoccurred.

A test, called the Cone Contrast Test (CCT), is used to determinedeficiencies of these cones in an individual's eye. The CCT is explainedin greater detail in the published articles titled “Rapid Quantificationof Color Vision: The Cone Contrast Test” by Rabin et al. published inInvestigative Ophthalmology & Visual Science, February 2011, Vol. 52,No. 2, and “Quantification of Color Vision with Cone ContrastSensitivity” by Jeff Rabin (2004), 21, pp. 483-485, the disclosures ofwhich are hereby incorporated by reference.

The CCT is a functional test, making it a broad, non-disease-specifictest. These features make CCT an affordable screening tool able todetect cone sensitivity degradation associated with a broad spectrum ofdisease/condition/toxicity early enough to, with treatment, potentiallyprevent permanent eye damage. The CCT may also be used as an earlyindicator for eye, systemic, and neurological disease and retinaltoxicity, as well as a monitoring test for disease/toxicity progressionand treatment.

Current testing procedures typically present a single colored letter,number, or symbol (e.g., a directionally oriented symbol or letter) atdifferent contrast levels, with subsequent presentation at a higher orlower color contrast levels based on a patient's response, until thevisual threshold is reached for that color. A patient typically respondsto such stimulus by touching a response pad on separate region of acomputer display, providing a verbal indication of the letter, number orsymbol, or using a separate response pad and selecting the matchingletter, number or symbol. Each of the above requires that a patientrecognize a particular letter, number, or symbol that is presented,which requires both color vision and visual acuity.

The patient must often look away from the stimulus; a patient's poorvisual acuity can interfere with testing procedures and results; and/orsuch types stimulus matching do not present well on computerized deviceshaving small displays, such as smart phones, headsets (e.g., virtualreality-type or augmented reality-type headsets, or smart watchesincluding displays, etc.).

When presented with a stimulus requiring matching, in most case, thepatient must refocus their gaze and search for a correct answer from aplurality of possibilities in order to provide an input via a separatecomputer display region or, which can lengthen test time considerably.Accordingly, as test time is important to a clinician, lengthy testtimes can hinder the acceptance or usefulness of a product. While adirectional stimuli, such as Landolt C's, used in combination with adirectional response pad may eliminate the need to look away from thestimulus, this method still requires both color vision and visual acuityto perceive the stimulus. Moreover, a response pad may prove difficultfor patients for patients that have problems with fine motor skills orare easily confused because any letter presentation inherently requiresthat the patient perform some type of matching, even if it is byfeel—this can prove challenging both from physical and mentalstandpoints.

While letters, numbers, and symbols can be presented at a large acuitysize, e.g., 20/200 or larger to minimize issues with visual acuity, aceiling effect exists for low vision patients. That is, patients withvisual acuity greater than 20/200 may be unable to identify a letter,number, or symbol due to limitations in their visual acuity, not theirability to see color. For example, patients with progressive diseasessuch as Retinitis Pigmentosa routinely have visual acuity less than20/200, therefore, such types of stimulus may not be particularlyeffective at managing the disease. Moreover, in the case of smallerdisplay areas, such as smartphone devices, it may not be possible toproperly present letters, numbers, or symbols of larger acuity size fortesting purposes limiting its usefulness for disease management evenfurther.

Response pads displayed on a screen can be overly space-consuming in thecase of smaller displays such as smartphones as these devices havelimited display space. Separate response pads typically requireconnection via available communications ports or the use of such portsmaking them impractical for smaller displays such as smartphones, asthey may not have the required ports. Moreover, wireless technologies,such as BlueTooth may be cost prohibitive to incorporate into a responsepad. Hence, letter, number, or symbol matching is impractical for asmaller, computer-based devices such as smartphones.

What is needed, then, are methods and devices that address the abovedeficiencies.

SUMMARY

At the outset it should be understood that while the followingdisclosure, figures, and/or claims, etc., describe subject matterincluding one or more aspects described as either alone or incombination with one or more other aspects, the subject matter of theinstant disclosure is not intended to be so limited. That is, theinstant disclosure, figures, and claims are intended to encompass thevarious aspects described herein, either alone or in one or morecombinations with one another. For example, while the instant disclosuremay describe and illustrate a first aspect, a second aspect, and a thirdaspect in a manner such that the first aspect is only specificallydescribed and illustrated relative to the second aspect, or the secondaspect is only described and illustrated relative to the third aspect,the instant disclosure and illustrations are not intended to be solimiting and may encompass the first aspect alone, the second aspectalone, the third aspect alone, or one or more combinations of the first,second, and/or third aspects, e.g., the first aspect and the secondaspect, the first aspect and the third aspect, the second and thirdaspect, or the first, second and third aspects.

According to aspects described and illustrated herein, there areprovided methods and apparatuses for administering a cone contrast colorvision test to a patient using a computer. The methods generally includethe steps of simultaneously displaying a first color at a first contrastlevel in a first region of a display and a background color in theremaining regions of the display, which display is in communication withthe computer, receiving a first input signal from the patient via aninput device in communication with the computer, where the first inputsignal is indicative of whether the patient recognizes the first colordisplayed in the first region at the first contrast level, displayingthe first color at a second contrast level in a third region of thedisplay, where the first and third regions are chosen randomly,receiving a second input signal from the patient via the input device,where the second input signal is indicative of whether the patientrecognizes the first color displayed in the third region at the secondcontrast level, assigning a score to the first and second input signals,the score related to a cone sensitivity of the patient to the firstcolor at the first contrast level, storing the score in a storagedevice, comparing the score to at least one previous score associatedwith the patient to calculate a progression of a cone sensitivity lossin the patient, and displaying a graphical representation of theprogression of the cone sensitivity loss in the patient. In anadditional aspect, the first color at different contrast levels may bepresented simultaneously in differing regions, e.g., first, third, andfifth regions, etc., where the input signal is indicative of the lowercolor contrast level the patient is able to see.

In an additional aspect, the first color comprises one of red, green, orblue, and the second color is grey. In further aspects, the secondcontrast level of the first color is different than the first contrastlevel of the first color. In some aspects, when the first and secondregion are simultaneously displayed, the first region does notsimultaneously occupy the second region.

In some aspects, the first and third regions are disposed in one of anupper, leftward, rightward, or lower region of the display and aposition of the first and third regions are randomly selected.

In some aspects, the first and second input signals comprise at leastone of a touch input, a voice input, or an eye tracking input, and theinput device is attached to and implemented via the computer.

In some aspects, at least one of the first and second contrast levels isset to a predetermined default value if there are no prior cone contrastcolor vision test records associated with the patient.

In some aspects, steps (a) through (f) are repeated sequentially usingvalues for the first and second contrast levels based on the values forthe patient response of the first and second contrast levels in a prioriteration of the cone contrast color vision test to determine a lowestcone sensitivity of the patient.

In additional aspects, sine wave gratings are presented to measure apatient's contrast sensitivity as a function of their spatial frequency.The first and second contrast levels of the first and third regions arecreated by modifying the color saturation or intensity level of thefirst color using linear or concentric circle sinusoidal gratings,spatial dithering, or temporal dithering. In some aspects, the first andthird regions comprise a sign wave grating pattern formed using thefirst color presented between the first and second color saturation orintensity level, and thereby creating a specific color contrast level s.The patient's threshold for contrast sensitivity of the sine wavegrating is determined by increasing or decreasing the color saturationor intensity level based on the patient response until he can no longersee the linear or concentric circle gratings. In some aspects, the firstand second color contrast levels of the sign wave grating patternpresented by varying the spatial frequency (measured in cycles/degree)of the first color presented between the first and second intensitylevels.

In some aspects including sine wave grating, the first and third regionsare displayed in one of an upper, leftward, rightward, or lower regionof the display and a position of the first and third regions is randomlyselected. In some aspects including sine wave grating, the first andthird regions are displayed in a quadrant of the display and thequadrant of the first and third regions is randomly selected.

In some aspects, the first contrast level of the second color is thesame as the second contrast level of the second color. In some aspects,the first contrast level of the second color is different from thesecond contrast level of the second color.

In some aspects, there is described a method for displaying a simulateddepiction of the vision of a patient with cone sensitivity loss,including the steps of receiving on a computer at least one conecontrast color vision test record associated with the patient,displaying at least one sample image depicting normal vision withoutcone sensitivity loss on a display attached to the computer, modifyingthe at least one sample image into at least one modified image accordingto a specific level of cone sensitivity loss recorded in the at leastone cone contrast color vision test record associated with the patient,such that the at least one modified image depicts the at least onesample image as it would been perceived by the patient, and displayingthe at least one modified image on the display.

While the inventive aspects are susceptible of embodiments in manydifferent forms, there is shown in the drawings and will herein bedescribed in detail preferred aspects with the understanding that thepresent disclosure is to be considered as an exemplification of theprinciples of the inventive aspects and is not intended to limit thebroad inventive aspects to the specific embodiments illustrated.

The inventive aspects include a method and apparatus for screening andmonitoring progression and treatment of retinal disease, glaucoma,neurological disorders and other systemic pathologies affecting the eye.The method and apparatus include a Cone Contrast Test (CCT) whichmeasures and scores color perception by cone type and assigns a score bycone type. The method and apparatus further include a comparison of suchscores to a base line. Using CCT for the screening of potentialdisease/toxicity is an efficient, fast and low-cost procedure.

The apparatus comprises a computer, including input device and displaydevice, for administering the CCT to individuals and, based on the testresults and other factors, determining the early and late stages of oneof Glaucoma, Retinopathy, Age-Related Macular Degeneration, MultipleSclerosis, potentially Alzheimer's Disease and Parkinson's Disease, aswell as Retinal Toxicity due to high-risk medications, as disclosed inthe Appendices. The method is implemented by the apparatus.

In one presentation the Cone Contrast Test presents random coloredregions or areas, in an alternate presentation, a single object ispresented for a yes/no response so as to excite the red, green and bluecones in decreasing contrast sensitivity levels to identify thepatients' Cone Contrast threshold and score for each cone type in eacheye.

Upon each presentation of a colored region or area, the patient selectsthe perceived corresponding region by means of touching that region orarea of a touchscreen display upon which the colored region isdisplayed, by mean of providing a voice command in conjunction withvoice recognition software executed on a computer, for example, or bymean of an eye tracking input as may be provided by eye-trackingsoftware executed on a computer. If the patient does not see a coloredregion, a “Pass” option may be provided using any of the above methods.

The patient interface consists of a computer (e.g., a desktop, a laptop,or smartphone, headset, etc.), a display, and an input mechanism, whichmay include a touch screen, a microphone in communication with acontroller executing voice recognition software, or a camera or opticalsensor in conjunction with a controller executing eye-tracking softwarecapable of tracking eye movements or patient gaze or camera inconjunction with a controller executing gesture-tracking softwarecapable of tracking hand gestures.

The Cone Contrast Test in fully automated, presenting each region orarea for a specific, limited duration. Limiting the presentation timespeeds up the test and may prevent a color deficient patient frompotentially perceiving visual clues to aid in a response and potentiallyaffecting the score.

Further, elderly pateints may not be familiar with computers, and thusmay not be a responsive even though they are not color deficient. A“blanking period” option may be selected for pateints requiring moretime with the response unit. Specifically, after the region or area ispresented for a fixed duration, the target region or area is removedfrom the screen. The “blanking period” allows older pateints, as well aspatients with physical or cognitive limitations enough time to respondwithout introducing visual clues that could potentially alter theiractual threshold and score.

Alternatively, an Orientation Screen, presented prior to the test foreach eye, may detect the actual response time for the individual patientand adjust the presentation time for each region or area to achieve aPatient-Specific Presentation Time that would accommodate the need foradditional response time due to computer, physical or cognitivelimitations of each individual patient.

The blanking option of patient-specific presentation time is a keycomponent for the Early Eye Disease Detection and Monitoring componentof the Cone Contrast Test, as the majority of pateints developing eyedisease are elderly and may need extra time to respond due tounfamiliarity with a computer or smartphone or physical or cognitivelimitations.

In an example embodiment, the administration of the test is sped up byusing a “learning” test algorithm based on the patient's prior CCT testresults. The CCT test updates the patient's record automatically oncompletion of the CCT test. Alternately, the contrast scores may beentered manually from the patient's prior CCT exam. This learning testalgorithm significantly reduces the number of cone contrast levelspresented on future presentations.

The following fields are included on the Patient Record to be accessedby the CCT test: Last red cone contrast score left eye, Last green conecontrast score left eye, Last blue cone contrast score left eye, Lastred cone contrast score right eye, Last green cone contrast score righteye, Last blue cone contrast score right eye.

At the commencement of the CCT test, the patient record is read for lastcone contrast scores. If no previous scores are found, it is assumedthat this is a new patient and the test continues with the normalalgorithm. And, if any last cone contrast values from the patient recordlisted above have a value, the starting cone contrast level is alteredbased on the last cone contrast score for that eye/cone. If a last conecontrast score is found in the patient record, the test calculates thecorresponding cone contrast level and begins the CCT Test for that cone1-2 levels above the corresponding cone contrast score for that eye. Ifmultiple values are found, the CCT test alters each corresponding partof the test accordingly.

In an example aspect, a staircase method is used to present colorcontrast levels by cone type, allowing the test to be administered morequickly. The contrast presentations are reduced by two levels at a timeif the patient correctly identifies the character at that contrastlevel. The contrast level is increased if two or more regions or areaswithin a contrast level are incorrectly identified. The algorithm foreach cone can be altered individually or in combination based on thefields populated in the patient record.

The colors presented are precisely selected to excite only one cone typeat a time, allowing each cone type to be measured and scoredindependently.

Off-the-shelf equipment is calibrated for both color and contrast. Thecolor presentation must be accurate so that each cone type is testedindividually (i.e., only one cone type responds). In turn, the accuracyof the color contrast levels is important to determine threshold level.Custom equipment with superior displays may not require ongoingcalibration.

The current system can include software that does not allow othersoftware to change color or contrast calibration settings, to achieve areliable computerized color vision test using a low-cost colormeter.

The disclosed system can utilize display calibrating colormeterhardware, such as SPYDER X™ and related versions, manufactured and soldby DATACOLOR of Lawrenceville, NJ.

Since the CCT begins with establishing a baseline for each cone type foran individual and looks for degradation of the individual's colorperception through repeated testing over time, stable color contrastlevels are critical. This may be accomplished through system calibrationfor custom hardware. Computer equipment and colormeters can be changed,drift or fail over time, allowing color and contrast values to becomeout of calibration. To ensure that equipment stays within calibrationand test results remain valid, the software forces an automatic in-fieldperiodic calibration check. The CCT is self-calibrating, requiring theuser only to position the photometer on the monitor and start thecalibration. The calibration verification is done automatically andchecks calibration values to original calibration values done at initialmanufacturing. If the calibration is outside of tolerance, the systemforces a complete calibration. If the calibration is still outside oftolerance, the system will alert the user and disable the use of theCone Contrast Test until calibration can be completed within tolerance.

The duration between each calibration is established during set-up andmay be adjusted based on clinic testing policy and procedure. Thecalibration time frame can be pre-set for every seven days but may beset according to individual testing policy and preference. Preferably,calibration automatically occurs at a predetermined interval of time.The automation alleviates the fear by some that the calibration may beskipped and test results may be rendered invalid.

Automated calibration verification enables a user to check forfailing/failed hardware, including colormeter, monitor, or computerchanges to ensure valid test scores. The calibration verification of thepresent system is preferably set at a seven (7) day interval, requiringcalibration be checked against the original calibration settings. Anysignificant change from original calibration settings requires a fullcalibration. If a full calibration is still outside of tolerances, theCone Contrast Test is disabled until a calibration can be completedwithin tolerance. Replacing equipment, such as a photometer, monitor orCPU, may be required to achieve a valid calibration.

Since the equipment may be used for both screening and monitoring ofdisease/toxicity, the equipment has both a screening mode and acomprehensive testing mode to allow for Medicare or other insurancebilling, with the comprehensive mode providing more thorough examinationand reporting. A doctor specifies the mode based on the use of theinstrument for the specific exam before conducting the test.

Variations in the testing method may include, but are not limited to (1)altering distance between a display screen and an individual (e.g., 3, 4or 6 meters), (2) a user interface such as voice recognition commands,wireless keyboards or other wired or wireless input devices, (3)blanking period or patient-specific response time, and (4) screening andtesting modes.

Each test is scored by cone type and any cone deficiency is determinedby comparing the patient's scores over time. Accuracy of CCT is veryhigh in detecting Red, Green and Blue cone deficiencies. Deficiencieswhich present over time are predictive of early ocular, systemic andneurological disease as well as retinal toxicity, whereas suchdeficiencies may otherwise be overlooked as anomalies.

Storing of cone contrast sensitivity scores and reporting data in a waythat shows cone contrast sensitivity changes over time allows forpotential disease/toxicity alerts. Reports show a change in conecontrast sensitivity by patient, per eye, by cone type and display analert when the cone contrast sensitivity change is statisticallysignificant. The reports can be viewed or printed to alert doctors andpatients of potential disease or toxicity that should be furtherinvestigated.

Currently, significant change is thought to be the normal distributionof color normal patients score, >15 points. Further research may showthat changes less than 15 points may also be significant to a specificpatient baseline.

This type of tracking and reporting mechanism has never before beenavailable, limiting prior art systems and methods to hereditary colordeficiency scoring use or research where time permits for manualcomparison. The disclosed system and methods are the first CCT usable asan early eye, systemic and neurological disease and retinal toxicitydetection system in a clinic setting, where time with the patient islimited. Comparison data and alerts are critical to interpret testresults in the time frame required in a clinical setting.

Patient reports may be stored on a non-transitory computer readablemedium such as a hard drive or memory device and may be uploaded toelectronic medical records. In addition to running the test andcomputing and storing the test results on a single computer, the testmay be run on any of a number of smartphones, smartwatches, headsets,laptops, networked or standalone computers, and the test results may becomputed and/or stored on any of a network of computers. Thisarrangement ensures that a patient need not take a subsequent test onthe same computer to ensure his record is present, and it allows for thesharing of the test results and patient records between computers indistant physical locations. The network of computers may include locallynetworked computers, Bluetooth connected computers, or computersconnected through shared access to the Internet or a cloud of computers.

In an example embodiment, the computers implementing the CCT test use async function consisting of three steps: 1. identifying the CCTcomputers in the network to be synced into a central network database,2. identifying and uploading the records from each CCT device on thenetwork which need to be synced with the central network database; 3.identifying and download the records in the central network databasewhich need to be downloaded and which local CCT device requires thedownload.

A sync file containing the practice name and unique device identifierfor each CCT device is established as part of the setup of the centralnetwork database to control which devices get synced to the centralnetwork database. Proprietary sync software, located on the network,accesses all devices in the sync file network, syncs activity from thelocal databases into a single network database, and syncs each localdevice database with the contents of the central network database. Thesync function can be scheduled for the same day and time or startedmanually. A sync timer setting is available as a system setting,residing on the network database which establishes the day and time fora scheduled sync.

An upload sync flag is part of the patient file as well as the patienttest records file. Upon the completion of the addition or change to apatient record, the upload sync flag in the patient file is set to 1,flagging the file to be uploaded to the central network database uponthe next sync. Upon the completion or deletion of a patient test, thepatient test record upload sync flag is set to 1, flagging the file forupload to the central network database upon the next sync.

Upon the execution of the upload sync function, each uploaded patient orpatient test record sync flag is set to 0, flagging the record asalready synced. Download sync flag(s) 1 through x, based on the numberof local CCT devices in the sync file, are also part of both the patientfile as well as the patient test records file. As each record isuploaded to the network database, a download sync flag is set to theunique device identifier of the contributing CCT device.

Upon the download sync function, the first local CCT device in the syncfile is accessed. Records in the central database that do not includethe download sync flag for that local device are downloaded. After eachrecord is downloaded to the local machine, the unique device identifieris added to the record on the central network database. Each local CCTdevice listed in the sync file is accessed in a similar manner. Sinceeach record tracks the devices that have been synced, additional devicesmay be added at any point in time and are able to be synced into thenetwork.

The patient test file also has a test device field. Upon the completionof the CCT test, the unique device identifier is recorded in the testdevice field. The test device field is used to identify the device onwhich the test was taken in the event that the test has erroneous oroutlying results that may signify a device which needs to berecalibrated or otherwise serviced.

In an example aspect, all records are copied to the central networkdatabase and repopulated to each local database.

As previously discussed, patient response time is captured and recordedfor each cone type for every Cone Contrast Test. Mean response time bycone type, and by eye, is calculated and reported. Response times havebeen shown to correlate closely with cone deficiency, with color normalpatients responding consistently within two seconds and color deficientpatients responding much slower. Cone Contrast Sensitivity Response Timemay serve as a new sensitive metric of color deficiency and earlyindicator of eye, systemic or neurological disease.

These and other aspects, features, and advantages of the presentdisclosure will become readily apparent upon a review of the followingdetailed description of the disclosure, in view of the drawings andappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects are disclosed, by way of example only, with reference tothe accompanying drawings in which corresponding reference symbolsindicate corresponding parts, in which:

FIG. 1 is a screen shot of an inventive aspect;

FIG. 2 is a screen shot of an inventive aspect;

FIG. 2 a is a screen shot of an inventive aspect;

FIG. 2 b is a screen shot of an inventive aspect;

FIG. 3 is a screen shot of an inventive aspect;

FIG. 3 a is a screen shot of an inventive aspect;

FIG. 3 b is a screen shot of an inventive aspect;

FIG. 4 is a screen shot of an inventive aspect;

FIG. 5 is a screen shot of an inventive aspect;

FIG. 6 is a screen shot of an inventive aspect;

FIG. 7 is a screen shot of an inventive aspect;

FIG. 8 is a screen shot of an inventive aspect;

FIG. 9 is a screen shot of an inventive aspect;

FIG. 10 is a screen shot of an inventive aspect;

FIG. 11 is a screen shot of an inventive aspect;

FIG. 12 is a screen shot of an inventive aspect;

FIG. 13 is a screen shot of an inventive aspect;

FIG. 14 is a screen shot of an inventive aspect;

FIG. 15 is a report of an inventive aspect;

FIG. 15 a is a report of an inventive aspect;

FIG. 16 is a report of an inventive aspect;

FIG. 16 a is a report of an inventive aspect;

FIG. 17 is a report of an inventive aspect;

FIG. 17 a is a report of an inventive aspect;

FIG. 18 is a report of an inventive aspect;

FIG. 18 a is a report of an inventive aspect;

FIG. 19 is a screen shot of an inventive aspect;

FIG. 20 is a screen shot of an inventive aspect;

FIG. 21 is a report of an inventive aspect;

FIG. 22 is a report of an inventive aspect;

FIG. 23 is a diagram of an inventive aspect;

FIG. 23 a is a diagram of an inventive aspect;

FIG. 23 b is a diagram of an inventive aspect;

FIG. 24 is a diagram of an inventive aspect;

FIG. 24 a is a diagram of an inventive aspect;

FIG. 24 b is a diagram of an inventive aspect;

FIG. 25 is a flow chart of an inventive aspect;

FIG. 26 is a schematic view of an inventive aspect;

FIGS. 27A-27C schematically illustrate a region or area-type conecontrast color vision test utilizing a quadrant-type system;

FIGS. 28A-28C schematically illustrate a region or area-type conecontrast color vision test utilizing a directional-type system;

FIGS. 29A-29D schematically illustrate a region or area-type conecontrast color vision test utilizing a linear and/or circular sine-wavegrating system;

FIGS. 30A-30C schematically illustrate a region or area-type conecontrast color vision test utilizing spatial or temporal dithering;

FIGS. 31A-31B schematically illustrate a so-called real-time region orarea-type cone contrast color vision test;

FIGS. 32A and 32B schematically illustrate a region or area-type conecontrast color vision test; and,

FIGS. 33 and 34 schematically illustrate a sequencing-type cone contrastcolor vision test.

DETAILED DESCRIPTION

At the outset, it should be appreciated that like drawing numbers ondifferent drawing views identify identical, or functionally similar,structural elements of the embodiments set forth herein. Furthermore, itis understood that these embodiments are not limited to the particularmethodology, materials and modifications described and as such may, ofcourse, vary. It is also understood that the terminology used herein isfor the purpose of describing particular aspects only and is notintended to limit the scope of the disclosed embodiments, which arelimited only by the appended claims.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood to one of ordinary skill inthe art to which this disclosure pertains. It should be understood thatany methods, devices or materials similar or equivalent to thosedescribed herein can be used in the practice the example aspects.

It should be appreciated that the terms “substantially” and “generally”are synonymous with terms such as “nearly,” “very nearly,” “about,”“approximately,” “around,” “bordering on,” “close to,” “essentially,”“in the neighborhood of,” “in the vicinity of,” etc., and such terms maybe used interchangeably as appearing in the specification and claims. Itshould be appreciated that the term “proximate” is synonymous with termssuch as “nearby,” “close,” “adjacent,” “neighboring,” “immediate,”“adjoining,” etc., and such terms may be used interchangeably asappearing in the specification and claims. The term “approximately” isintended to mean values within ten percent of the specified value.

As set forth herein, the term “computer” is intended to refer to anelectronic type computing device generally including a processor and amemory device, and may include one or more of display device, a wired orwireless input device such as a keyboard, mouse, touchscreen,microphone, motion sensor, camera, photosensor, eye tracking sensors,touchpads, handheld responder, remote, etc., or other input electronicdevice, as well as other output devices such as loudspeakers or othervisual or devices capable of outputting sensory indicia, e.g., sounds,lights, vibrational cues. etc. A “computer”, thus, may include devicessuch as a desktop or laptop computer, a so-called tablet computer, asmartphone, and/or a so-called smart-watch or virtual reality oraugmented reality headset device that may or may not be in communicationwith another device, and like devices.

It should be understood that use of “or” in the present application iswith respect to a “non-exclusive” arrangement, unless stated otherwise.For example, when stating that “item x is A or B,” it is understood thatthis can mean one of the following: (1) item x is only one or the otherof A and B; (2) item x is both A and B. Alternately stated, the word“or” is not used to define an “exclusive or” arrangement. For example,an “exclusive or” arrangement for the statement “item x is A or B” wouldrequire that x can be only one of A and B. Furthermore, as used herein,“and/or” is intended to mean a grammatical conjunction used to indicatethat one or more of the elements or conditions recited may be includedor occur. For example, a device comprising a first element, a secondelement and/or a third element, is intended to be construed as any oneof the following structural arrangements: a device comprising a firstelement; a device comprising a second element; a device comprising athird element; a device comprising a first element and a second element;a device comprising a first element and a third element; a devicecomprising a first element, a second element and a third element; or, adevice comprising a second element and a third element.

As previously set forth, while the following disclosure and accompanyingfigures, and/or claims, etc. describe subject matter including one ormore aspects described as either alone or in combination with one ormore other aspects, the subject matter of the instant disclosure is notintended to be so limited. That is, the instant disclosure, figures, andclaims are intended to encompass the various aspects described herein,either alone or in one or more combinations with one another. Forexample, while the instant disclosure may describe and illustrate afirst aspect, a second aspect, and a third aspect in a manner such thatthe first aspect is only specifically described and illustrated relativeto the second aspect, or the second aspect is only described andillustrated relative to the third aspect, the instant disclosure andillustrations are not intended to be so limiting and may encompass thefirst aspect alone, the second aspect alone, the third aspect alone, orone or more combinations of the first, second, and/or third aspects,e.g., the first aspect and the second aspect, the first aspect and thethird aspect, the second and third aspect, or the first, second andthird aspects.

It will be appreciated that various aspects of the disclosure and otherfeatures and functions, or alternatives thereof, may be desirablycombined into many other different systems or applications. Variouspresently unforeseen or unanticipated alternatives, modifications,variations, or improvements therein may be subsequently made by thoseskilled in the art which are also intended to be encompassed by thefollowing claims.

As discussed above, a cone contrast test may use a staircase method ofdetecting a patient's cone contrast threshold by presenting coloredletters specific to each cone type in decreasing and/or increasingcontrast steps until reaching the patient's threshold for that specificcone type. It tests all three color values-red, green and blue-in bothright and left eyes. Characters or optotypes are presented at 20/200(red, green) and 20/300 (blue) to avoid acuity function interference.The CCT presents letters at 5 color contrast levels, decreasing by twocolor contrast levels or jumps until the patient responds incorrectly.At that time, the color contrast level presentations begin at the nexthigher color contrast level and proceeds in a sequential fashion throughthe duration of the test. The patient's cone score is determined basedon the number of correct responses at each level.

Adverting now to the Figures, the following Figures show screenshots oftesting software 100. FIG. 1 shows sign in screen 101 driven by acomputer. Sign in screen 101 comprises user name field 102, passwordfield 103, and sign in button 104. Upon commencing testing software 100,sign in screen 101 appears. In order to access testing software 100, apatient taking a CCT or an administrator directing the CCT, must input auser name and a password into user name field 102 and password field103, respectively. A user can exit testing software 100 by selectingexit button 105 located at the top right of sign in screen 101.

Once sign in button 104 is selected, presentation option screen 106 oftesting software 100 appears as shown in FIG. 2 . Presentation optionscreen 106 comprises CCT near button 108, CCT distance button 109,contrast acuity near button 110, contrast acuity distance button 111,contrast sensitivity distance button 112, and reports button 113. TheCCT may be conducted while a patient is seated at a desk with thecomputer displaying the CCT mounted thereon. In this case, a patient canuse a computer mouse or some other means to select buttons in testingsoftware 100 to be described in more detail below. Alternatively, theCCT may be conducted while a patient is seated or standing a distancefrom the computer displaying the CCT. In this case, an administratordirecting or overseeing the CCT can operate a mouse in communicationwith the computer displaying the CCT or some other interface may beinvolved to input a patient's responses. For example, voice recognitionsoftware could be used to transmit a patient's selections in orresponses to the CCT, or a wireless mouse could be used. In an exampleembodiment, the patient responds by verbally announcing the character orsymbol displayed on the display monitor. In addition to theaforementioned case in which the technician enters the patient's verbalresponse, the patient's verbal response may be received by a microphoneattached to the computer. Voice recognition software running on thecomputer then translates the patient's verbal response into a textualresponse identical to text input from a keyboard. Use of computer voicerecognition is selectable and may be turned off on a case by case basis.In an example embodiment, speakers, and wireless or wired headphones orheadsets may be used to relay audible instructions or indications to thepatient. Headphones may better accommodate both voice recognition andthe voice confirmation of patient responses for patients at longerdistances or in test environments in which multiple devices are beingused in a small area.

Regardless of the method used, CCT can be administered with a patientarranged proximate the display screen and at a distance away from thedisplay screen. If CCT near button 108 or contrast acuity near button110 is selected, testing software 100 is directed to use characters at adefault size based on the calibration of testing software 100. If CCTdistance button 109 is selected, testing software 100 is directed todisplay higher quality characters, down to 20/10, during the CCTdepending on the patient's distance from the computer display. SelectingCCT distance button 109 will cause testing software 100 to produce adistance field and the patient's distance from the computer display willneed to be inputted into the distance field and transmitted to testingsoftware 100 so the properly sized characters are used. For bestresults, the patient should be parallel to the display. Selectingcontrast acuity distance button 111 or contrast sensitivity distancebutton 112 will similarly direct testing software 100 to use higherquality characters, down to 20/10, during the acuity or sensitivitytests depending on the patient's distance from the computer display.Reports button 113 will be discussed in more detail below.

In an example embodiment, the CCT test is presented to the patient as anenclosed device. Specifically, the enclosed device includes the computerimplementing the CCT test, the display to be viewed by the patient, achin rest arranged at a predetermined distance from the display (seeFIG. 26 ), and the input device. The patient places his forehead andchin on the chin rest and the characters or symbols are presented on thedisplay. In an example embodiment, the enclosed device uses mirrors,projection or magnification to size the letters to the desired testdistance. The enclosed device allows the distance CCT test to beadministered in a much smaller area, such a pre-test or screening roomand enforces a predetermined distance between the display and thepatient's eyes.

For consistent results, lighting should controlled. The CCT should beconducted in dim room lighting. No light should be directed at the CCTdisplay. However, some indirect lighting is acceptable and will notinterfere with the test.

Selection of the type of test desired (CCT near button 108, CCT distancebutton 109, contrast acuity near button 110, contrast acuity distancebutton 111, or contrast sensitivity distance button 112) will directtesting software 100 to produce subject data screen 116. Subject datascreen 116 comprises patient ID field 114 and patient name field 115shown in FIG. 3 . Patient ID field 114 of testing software 100 isarranged to receive a 1-10 digit number identifying a patient. Thenumber can be input using a keyboard, for example. A patient's name, forexample, John Doe is inputted into patient name field 115 using akeyboard, for example. It should be appreciated that other means suchas, voice recognition software could be used to populate patient IDfield 114 and patient name field 115. To start the test, a patient or anadministrator presses the “Enter” button on a keyboard. The test can bestarted without inputting data into patient ID field 114 and patientname field 115. A user can exit testing software 100 by selecting exitbutton 105 located at the top right of subject data screen 116.

The CCT test can be implemented using any characters preferably, lettersor numbers. For Dyslexic patients, conducting the test using numbers mayyield more favorable results. In an example embodiment, Snellen lettersand/or non-character symbols may be used in the administration of thetest. Examples of these non-character symbols include, but are notlimited to, children's symbols, such as Allen Symbols, Lea Symbols orPatti Pics Symbols, as well as other ophthalmic symbols such as TumblingEs or Landolt Cs. In the case of Tumbling Es or Landolt Cs, theresponses would include left, right, up and down.

FIG. 4 shows orientation testing screen 200. Orientation testing screen200 comprises orientation instruction pane 201, confirmation button 203,testing field 211, testing symbol 212, response table 213, and passbutton 214. Response table 213 comprises plurality of response symbols215. In some embodiments of the invention, orientation testing screen200 is displayed immediately upon commencement of the CCT process. Bydisplaying orientation testing screen 200 prior to other portions of theCCT, the method of taking the CCT can be relayed and practiced by thepatient taking the CCT. Orientation instruction pane 201 containswritten instructions on the specific steps the patient taking the CCTshould take during the testing process. Orientation instruction pane 201also contains instructions for advancing to the other portions of theCCT.

In the embodiment of the invention shown in FIG. 4 , the writteninstructions in orientation instruction pane 201 instruct the patienttaking the CCT to identify testing symbol 212 in testing field 211 andselect the equivalent symbol from the plurality of response symbols 215in response table 213. In some embodiments of the invention, thespecific symbols included in response table 213 will be selectedrandomly, but in all embodiments of the invention, a symbol equivalentto testing symbol 212 must be one of response symbols 215 in responsetable 213.

This initial selection of one of the symbols of the plurality ofresponse symbols 215 in response table 213 highlights the selectedsymbol for review by the patient. In some embodiments of the invention,selecting one of the plurality of response symbols 215 will causetesting software 100 to produce a sound corresponding to the symbolselected, such as saying the name of the letter if the plurality ofresponse symbols 215 are letters. Selecting the same symbol again willact as a confirmation and indicate to testing software 100 that thepatient believes the symbol selected from the plurality of responsesymbols 215 in response table 213 to be the same as the testing symbol212.

If the patient taking the CCT cannot identify testing symbol 212, thepatient may select pass button 214. This will indicate to testingsoftware 100 that the patient is unable to identify testing symbol 212.In some embodiments of the invention, selecting the pass button will berecorded as an incorrect identification for patient color visionassessment purposes.

Upon confirmation of a symbol from the plurality of response symbols 215in response table 213 or selection of pass button 214, testing software100 will record the response and orientation testing screen 200 willrefresh. Upon refreshing, orientation testing screen will display a newtesting symbol 212. The patient taking the CCT will then select one ofthe plurality of response symbols 215 in response table 213 or passbutton 214, continuing the orientation process. When the patient isconfident that he or she understands the method of taking the CCT, theorientation process can be ended by selecting the confirmation button203.

FIG. 5 shows test commencement screen 230. Test commencement screen 230comprises commencement message 231, confirmation button 203, responsetable 213, and pass button 214. Response table 213 comprises pluralityof response symbols 215. Test commencement screen 230 is displayedimmediately prior to the commencement of the testing portions of the CCTto announce that the test process is ready to begin. The patient takingthe CCT will select confirmation button 203 when they are ready to beginthe testing process. Although response table 213 and pass button 214 arecomponents of test commencement screen 230, they are not active, i.e.,they cannot be selected.

FIG. 6 shows eye selection screen 232. Eye selection screen 232comprises eye selection message 233, confirmation button 203, responsetable 213, and pass button 214. Response table 213 comprises pluralityof response symbols 215. Eye selection screen 232 is displayedimmediately prior to each of the two eye-specific portions of the CCT.As color vision can be different in the left and right eyes of thepatient taking the CCT, it is beneficial to test the left and right eyesindividually. By testing the left and right eyes individually, a morethorough understanding of the patient's color vision can be obtained.

Eye selection message 233 indicates which eye will be tested in thefollowing test portion. For example, if the right eye is to be tested inthe following test portion, eye selection message 233 would instruct thepatient to cover their left eye and perform the test with their righteye only. The patient taking the CCT will select confirmation button 203when they are ready to begin the testing process for the eye indicatedin eye selection message 233. Although response table 213 and passbutton 214 are components of eye selection screen 232, they are notactive, i.e., they cannot be selected.

FIG. 7 shows color phase screen 234. Color phase screen 234 comprisescolor phase message 235, response table 213, and pass button 214.Response table 213 comprises plurality of response symbols 215. Colorphase screen 234 is displayed immediately prior to each of the threecolor-specific phases of the visual acuity test.

The ability of humans to perceive different colors of light is madepossible by specialized photoreceptor cells in the retina called conecells. Each of the three different types of cone cells detects adifferent portion of the visual spectrum, and each type is mostsensitive to a certain color of light. The three different types of conecells are most sensitive to colors that correspond approximately to thecolors of red, green, and blue. Colors other than red, green, and blueare perceived via the combination in the human brain of signals frommultiple types of cone cells and their relative intensities. Forexample, the color yellow is perceived when the red and green cone cellsare stimulated approximately equally. The phenomenon of perceiving thefull spectrum of visible light based on the combination of signals fromthree types of cells, each of which detects a different color, is calledtrichromacy.

As human vision is trichromatic, deficiencies in one or more of thetypes of cone cells can impair the ability of an individual to perceivecertain colors. However, because each type of cone cell is mostsensitive to a certain color of light, it is possible to individuallyassess the sensitivity of cone cells of a certain type by testing theability to distinguish image components made of the color that thecorresponding type of cone cell is most sensitive to. For this reason,the CCT has three phases for each eye, a red phase, a green phase, and ablue phase. For example, in the red phase, the sensitivity of thered-type cone cells is assessed. In this way, the sensitivities of thered-type, green-type, and blue-type cone cells in each eye can beassessed.

Color phase message 235 announces to the patient taking the visualacuity test which color phase is about to begin. As the patient does notneed to prepare for the specific color phases, the patient does not haveto select any particular interface component to continue to the portion.The test process will continue automatically after a predeterminedamount of time. Although response table 213 and pass button 214 arecomponents of color phase screen 234, they are not active, i.e., theycannot be selected.

FIG. 8 shows testing screen 210. Testing screen 210 comprises testingfield 211, testing symbol 212, response table 213, and pass button 214.Response table 213 comprises plurality of response symbols 215. Havingfamiliarized themselves with the testing method during the orientationportion of the CCT, the patient taking the test will be able to performthe test without further instruction. Testing symbol 212, is either red,green, or blue, depending on which color phase the testing process iscurrently in. For example, in the red color phase of the testingprocess, testing symbol 212 will be red.

The sensitivities of the different types of cone cells is assessed byshowing the patient taking the CCT a testing symbol 212 of the colorexciting only the cone type of the present color phase on testing field211. Initially, there is a large contrast differential between testingsymbol 212 and testing field 211. Due to this high contrastdifferential, it is easier for the patient to distinguish the shape oftesting symbol 212 and select the equivalent symbol from the pluralityof response symbols 215 in response table 213. By iteratively reducingthe contrast differential between testing symbol 212 and testing field211 and asking the patient to select the equivalent symbol from theplurality of response symbols 215 in response table 213, until thepatient is unable to correctly identify testing symbol 212, the abilityof the specific cone cell types of the patient's specific eye can beassessed.

In embodiments of the invention, a symbol equivalent to testing symbol212 must be one of response symbols 215 in response table 213.

This initial selection of one of the symbols of the plurality ofresponse symbols 215 in response table 213 highlights the selectedsymbol for review by the patient. In some embodiments of the invention,selecting one of the plurality of response symbols 215 will causetesting software 100 to produce a sound corresponding to the symbolselected, such as saying the name of the letter if the plurality ofresponse symbols 215 are letters.

If the patient taking the CCT cannot identify testing symbol 212, thepatient may select pass button 214. This will indicate to testingsoftware 100 that the patient is unable to identify testing symbol 212.In some embodiments of the invention, selecting the pass button will berecorded as an incorrect identification for patient visual acuityassessment purposes. Additionally, in some embodiments of the invention,if the patient does not select any of the plurality of response symbols215 in response table 213 in a predetermined amount of time, suchinaction will be recorded as an incorrect identification for patientcolor vision assessment purposes. The predetermined amount of timebefore an incorrect identification is registered may be varied dependingon the purpose of the color vision test. For example, if the purpose ofthe test is to measure hereditary color vision deficiency of pilotsand/or pilot applicants, the ability to make timely determinations maybe more important than if the purpose of the test is to test foracquired color vision loss. In such a case, the predetermined amount oftime before an incorrect identification is registered may be reduced.

If the patient correctly identifies testing symbol 212 by selecting theequivalent symbol from the plurality of response symbols 215 in responsetable 213, testing software 100 will record a correct identification andcontinue the test process. In one embodiment of the invention, twocorrect identifications in succession by the patient at a specificcontrast differential level will cause testing software 100 to display atesting screen 210 with a testing symbol 212 two contrast differentiallevels lower than the immediately preceding testing symbol 212. In sometests, however, only one presentation may occur.

If the patient selects an incorrect response symbol from the pluralityof response symbols 215 in response table 213, then testing software 100will record an incorrect identification. If the patient selects passbutton 214, then testing software 100 will record that the patient choseto pass. In an embodiment of the invention, if the patient selects anincorrect response symbol from the plurality of response symbols 215 inresponse table 213, the testing software will display a testing screen210 with a testing symbol 212 one contrast differential level higherthan the immediately preceding testing symbol 212.

In yet another embodiment, if the patient correctly identifies twotesting symbols 212 of a given contrast differential level, even if suchcorrect identification is separated by an incorrect identification, or aselection of pass button 214, or the registering of an incorrectidentification by the lapsing of the predetermined amount of time, thenthe testing software will display a testing screen 210 with a testingsymbol 212 one contrast differential level lower than the immediatelypreceding testing symbol 212.

Generally, testing software 100 will start each phase of the testprocess by displaying a testing screen 210 with a testing symbol 212 ofa higher contrast differential with testing field 211. Upon registeringa predetermined number of correct identifications of testing symbols212, testing software 100 will begin displaying a series of testingscreens 210 with testing symbols 212 of a lower contrast differentialwith testing field 211. Upon registering a predetermined number ofincorrect identifications, or selections of pass button 214, or lapsesof the predetermined amount of time, testing software 100 will begindisplaying a series of testing screens 210 with testing symbols 212 of ahigher contrast differential with testing field 211. The testing processin a specific color phase will end after a predetermined number ofcorrect identifications are registered at a specific contrastdifferential level. Registering a large number of correctidentifications at a specific contrast differential level indicates thatthe patient cannot reliably distinguish and identify a testing symbol212 of lower contrast differential levels. The testing process in aspecific color phase may also end after pass button 214 has beenselected a predetermined number of times. Repeatedly selecting passbutton 214 indicates that the patient can no longer reliably distinguishand identify the series of testing symbols 212 that are being displayed.

FIG. 9 shows refreshed testing screen 210 comprising testing field 211,testing symbol 212 of reduced contrast differential with testing field211, response table 213, and pass button 214. Response table 213comprises plurality of response symbols 215. The patient taking the CCTwill attempt to correctly distinguish and identify testing symbol 212and select the corresponding symbol from the plurality of responsesymbols 215. If the patient is unable to distinguish and identifytesting symbol 212, they may select pass button 214 to cause testingsoftware 100 to display new testing screen 210.

FIG. 10 shows refreshed testing screen 210 comprising testing field 211,testing symbol 212 of further reduced color contrast differential withtesting field 211, response table 213, and pass button 214. Responsetable 213 comprises plurality of response symbols 215. The patienttaking the CCT will attempt to correctly distinguish and identifytesting symbol 212 and select the corresponding symbol from theplurality of response symbols 215. If the patient is unable todistinguish and identify testing symbol 212, they may select pass button214 to cause testing software 100 to display new testing screen 210.

FIG. 11 shows refreshed testing screen 210 comprising testing field 211,testing symbol 212 of even further reduced color contrast differentialwith testing field 211, response table 213, and pass button 214.Response table 213 comprises plurality of response symbols 215. Thepatient taking the CCT will attempt to correctly distinguish andidentify testing symbol 212 and select the corresponding symbol from theplurality of response symbols 215. If the patient is unable todistinguish and identify testing symbol 212, they may select pass button214 to cause testing software 100 to display new testing screen 210.

FIG. 12 shows refreshed testing screen 210 comprising testing field 211,testing symbol 212 of minimal color contrast differential with testingfield 211, response table 213, and pass button 214. Response table 213comprises plurality of response symbols 215. The patient taking the CCTwill attempt to correctly distinguish and identify testing symbol 212and select the corresponding symbol from the plurality of responsesymbols 215. If the patient is unable to distinguish and identifytesting symbol 212, they may select pass button 214 to cause testingsoftware 100 to display new testing screen 210.

Upon completion of a specific color phase in the testing process,testing software 100 will continue to the next color phase for thecurrently tested eye. If all color phases have been completed for thecurrently tested eye, testing software 100 will display eye selectionscreen 232 and continue the testing process with the next eye to betested. If all color phases for both eyes have been completed, the testprocess is complete.

FIG. 13 shows test conclusion screen 236. Test conclusion screen 236comprises conclusion message 237, response table 213, and pass button214. Conclusion message 237 informs the patient that the test process iscomplete. Although response table 213 and pass button 214 are componentsof test commencement screen 230, they are not active, i.e., they cannotbe selected.

Alternately, the CCT test may be performed as a low cone contrastscreening test. A separate cone contrast screening mode allows for thequick determination of whether a patient has decreased color vision andshould be monitored with the full CCT test. The cone contrast screeningmode presents only a limited number, for example, a single line, of conecontrast levels. Letter presentation times are the same as the CCT test.

The specific cone contrast level presented is based on the cone contrastthreshold of patients with normal vision. If the patient is unable tosee the letters at this cone contrast level, the test results asconsidered abnormal. The CCT Screening report will display the lowestcone contrast level the patient is able to see for each cone type pereye and whether the results are “Normal” or “Abnormal Cone ContrastVision”. If the patient has Abnormal Cone Contrast Vision, the reportwill include a recommendation that the patient be monitored with thefull CCT test. In an example embodiment, the cone contrast screeningtest presents only blue characters to determine whether the patienttaking the test has normal or abnormal cone contrast vision based onblue cone function.

Changes in color vision may be able to detect pre-pathology changes inthe retina, such as reduced macular pigment density. Thinning of themacular pigment has been linked with pre-AMD and may be slowed orreduced by nutraceuticals. In commencing the CCT test by displaying thelowest cone contrast level below human threshold and conducting the CCTtest by measuring in small increments around this threshold, it ispossible to detect pre-pathology changes in the patient's vision.

Viewing and Interpreting Results

Reports may be generated by patient, type of report, and dates. Togenerate a report for a particular patient, testing software 100 isarranged to select data connected to a patient ID. You may display alist of all tests for a patient as shown in FIG. 19 . Or, to printComparison Reports, select the type of report to be displayed, and thenselect the date range for the report. Use the mouse or TAB key to movebetween the types of reports. Double click or hit ENTER on the specificreport date to view specific exam results. Selecting Dates forComparison Reports to view comparison results select the date range tobe displayed. To display reports within a narrower time frame, forexample, since the beginning of treatment, you may select a subset ofthe available tests. Hold down the SHIFT key to select a date range orhold down the CTRL key to select specific tests. Use the PgUp and PgDnbuttons to select larger date ranges. When the desired test dates areselected, click or TAB to the Submit for Report Generation button toview the report.

Reports button 113 shown in FIG. 2 can be accessed to review andgenerate test results. Similarly, FIG. 14 shows report generator screen500. Report generator screen 500 comprises select all test dates button501 and submit for report generation button 502. If select all testdates button 501 is selected, testing software 100 is directed toinclude all test data in generating reports for interpretation. Ifselect all test dates button 501 is not selected, particular test datescan be selected from report generator screen 500. Once particular testdates are selected from report generator screen 500, for example,selected test date 503, selection of submit for report generation button502 directs testing software 100 to generate reports.

Reports are shown in FIGS. 15-18, 21-22 . Significantly, CCT scores areshown in red, green and blue. Red CCT scores are shown with a singledashed line connecting circles. Green CCT scores are shown as a barconnecting squares. Blue CCT scores are shown as a double dashed lineconnecting triangles. The circles, squares and triangles refer to CCTscores. The lines connecting the CCT scores are generated to show trendsand whether a patient's color vision is deteriorating. Some reportsinclude bar graphs (FIG. 16 ) and line graphs (FIG. 17 ). The colorsred, yellow and green are also used to indicate color deficiency,possible deficiency, and normal vision, respectively.

In an example embodiment, the test results, namely, the degree of conesensitivity loss, are stored in an electronic health record (EHR)associated with the patient. An interface to EHR transfers patient testresults from the CCT database to the EHR database. An interface from thecomputer systems implementing the CCT test to the computer systemsstoring EHR data ensures that all patient records are stored in a singlelocation. Unlike the central network database and central cloud databasewhich transfers CCT data to a central CCT database, the EHR interfacetransfers CCT data to an EHR database, allowing CCT data to be storedalong with the patient's other medical records. The EHR interface is aone-way interface moving data only from the CCT database to the EHRdatabase. An interface to EHR incorporates the transfer of individualtest reports in a format such as .pdf, individual test scores, or both.For each test, the EHR interface transfers the patient's CCT testresulting including: patient name, test comments, red cone contrastscore left eye, green cone contrast score left eye, blue cone contrastscore left eye, red cone contrast score right eye, green cone contrastscore right eye, and blue cone contrast score right eye.

The EHR interface is complementary to the integration of multiple CCTDevices over a computer network. Without the ability to store test dataon the local CCT device or ensure it is accessible on the local CCTdevice, such as transferring it over the Internet or from a cloud ofcomputers, progression analysis reports, a key component for patientmanagement, would not be available.

In an example embodiment, at the conclusion of the patient test, theinformation is stored in a temporary EHR upload file. Upon the next syncfunction, all records in the temporary EHR upload file are transferredto the EHR. A DICOM interface is a standardized information format forpatient records transfer. Transfer of data can be made directly to aspecific EHR database or to EHR collection software, such as the MHSGENESIS® product used by the United States Department of DefenseMilitary Health System.

Acquired and hereditary color deficiency can be interpreted based on aless than normal cone score in a single visit or as a drop in a specificcone score of more than 10 points from a patient's base-line. Normalcolor vision is indicated by a CCT score between 90-100. Possible colorvision deficiency is indicated by a CCT score between 75-89. Colordeficiency, hereditary or acquired, is indicated by a CCT score between0-74. Acquired and hereditary color deficiency overlap. However, thereare several characteristics that can help identify acquired vs.hereditary color deficiency. Hereditary color deficiency is indicated byselective degradation of red or green tests. Moreover, cone sensitivityscores are substantially symmetrical in the left and right eyes. Incontrast, acquired color deficiency is not as selective to cone typesand may show decreases on red, green and blue tests. Acquired colordeficiency also usually features asymmetrical cone sensitivity scores inthe left and right eyes as the disease advances at different rates ineach eye.

In an example embodiment, a patient's results in the CCT test can beused to create and display a simulated depiction of the patient'svision, so that people with normal vision can perceive how the conesensitivity loss affects the patient's vision. Patients with decreasedvisual function often have difficulty communicating the vision loss theyexperience and how it impacts their daily living. This is especiallytrue when their loss of vision has not yet impacted their visual acuity,i.e., they are 20/20 or near 20/20, but it is affecting their “qualityof vision” (e.g., color vision, contrast sensitivity, low luminancevision). Family and caregivers may find it difficult to understand thepatient's reduced abilities and may accordingly be unable to accommodatethe patient for their abnormal vision. It is important for family orcaregivers to better understand how the patient sees in specificsituations so they can better aid the patient in these situations.

This simulated cone sensitivity loss is designed specifically for familymembers or caregivers to “experience” how the patient sees. It consistsof a series of images which show the difference between how a normalperson sees a particular image and how the patient sees that image.Images depicting normal color vision, normal low luminance vision,normal contrast vision, etc. are first displayed. Each of these imagesis then altered based on the specific patient's test scores for thecolor vision test, low luminance test, contrast sensitivity test,contract acuity test, etc. to demonstrate how the specific patient seesthe same image(s). A single image may also be altered to combine theimpact of the patient's test results from multiple tests into a singleimage.

In addition to the above, testing equipment, devices and/ormethodologies can also be provided for purposes of addressing theproblems associated with the use of CCT testing devices and proceduresthat require individuals to refocus their gaze, identify and select anappropriate character from among a plurality of characters, and/or thatutilize letters, numbers, or characters that can be difficult forindividuals with low visual acuity to perceive.

Generally, in some aspects a so-called “Forced Choice” type stimuluspresentation is implemented wherein a cone-isolating colored stimulus ispresented in one of several sections of a display screen and theremaining sections are presented as a grey “background” color. In suchprocedures, a patient may respond by, for example, touching or clickingon the color stimulus on the display screen in the case of a touchscreendisplay, using a direction-oriented keypad, or providing a verbalresponse, i.e., 1st, 2nd, 3rd, 4th quadrant or up, down, left, right,etc., or via the use of eye tracking device and/or software. Otherpresentations options include multi-section pie shapes, 3-D space, etc.Based on the patient's correct or incorrect response, the color contrastlevel of the colored stimulus may be decreased or increased. The greysections can remain constant. The location of the colored stimulus canbe deliberate or random and change with each presentation. Testingcontinues until the patient's threshold for each color is determined andeach cone-isolating color (red, green, and blue) is repeated in the samefashion for each eye.

In another aspect, a color contrast stimulus is presented that does notrequire the recognition of a letter, therefore eliminating severalproblems associated with a stimulus with matching including: the needfor the patient to look away from the stimulus to find a response; theinterference of visual acuity; and/or the limitations of administeringthe test on a smaller, computer-based device, such as a smartphone. Ablock-type stimulus, or other relatively large area or regions, is usedin combination with the Forced Choice stimulus presentation mannerdescribed above. In this presentation, a colored block, area or regionis presented in one of several sections, with the remaining sectionspresented as a grey “background” color. The block, area or region may bein the shape of a square, circle, pie, blob, etc., and the patient canrespond by touching or clicking on the colored area or region on thescreen, by using a direction-oriented keypad, by providing a verbalresponse, or through eye tracking device and/or software. Based on thepatient's correct or incorrect response, the color contrast level of thecolored block, area or region is decreased or increased. The greysections remain constant. The location of the colored block can bedeliberate or random and can change with each presentation. The testcontinues until the patient's threshold for each color is determined andeach cone-isolating color (red, green, and blue) is repeated in the samefashion for each eye.

In further aspects, sine wave gratings, for example as described in“Perception Lecture Notes: Spatial Frequency Channels” (Prof. MichaelLandy,https://www.cns.nyu.edu/˜david/courses/perception/lecturenotes/channels/channels.html,last accessed Oct. 9, 2020), which is incorporated herein by referencein its entirety, which can be utilized for purposes of grey scalecontrast sensitivity testing by plotting a sinusoidal function oflightness, varying the contrast across different frequencies. Thehighest contrast level is created by varying the color presented in afull range of black to white. Varying the frequency of the sinusoidalfunction yields lines or circles which are closer or farther apart.Specific contrast levels are achieved by varying the intensity of thesinusoidal function for each spatial frequency. In the case of conecontrast testing, a sinusoidal function which varies in luminance ofcone-isolating colors (red, green, and blue) across a grating pattern isused to stimulate each cone type independently. Either linear orconcentric circle patterns can be presented for testing purposes. Insuch case, the linear or circular pattern can be presented as patternsof colors, with each color pattern fading in intensity of the same colorfrom a higher contrast to lower contrast level presenting a stimuluspattern of dark, medium, light, medium, dark intensity of the samecolor. In some presentations, the area around the sinusoidal pattern, orthe “background” is grey. While grey-scale contrast sensitivity can bemeasured by varying the contrast levels over many different spatialfrequencies, this method may not work effectively relative tocone-isolating colors as the number of presentations must be multipliedby three to accommodate the three cone types, which can make the testingprocedures too long or cumbersome so to be effectively used in practice.Hence, in some aspects, in such a cone-isolating color version, alimited number of spatial frequencies can be used to reduce the numberof stimuli required to complete the test. A preferred number of spatialfrequencies is one, the peak of the contrast curve. In such procedures,a sine wave grating may be presented as a single stimulus (either staticor modified in real-time) or as one of several areas or regions asdescribed above. In such cases, a patient may identify whether thesinusoidal image is perceived by identifying in which area or region thesinusoidal image is present. Based on the patient's correct or incorrectresponse, the color contrast level of the sinusoidal pattern isdecreased or increased. The grey “background” color contrast levelremains constant. The location of the sinusoidal stimulus can bedeliberate or random and may change with each presentation. Thepatient's threshold for that cone-isolating color may then be determinedby the lowest color contrast sinusoidal image the patient can see forthat color. The test continues until the patient's threshold for eachcolor is determined and each cone-isolating color (red, green, and blue)can be repeated in the same fashion for each eye.

Additionally, current procedures typically utilize a computer's abilityto produce color contrast at low contrast levels. However, off-the-shelfcomputers are typically only able to present a limited number of colorcontrast levels, which can limit the ability to measure very finedifferences in color perception required for the earliest detection ofdisease, disease progression, and/or therapy improvement, and there is aneed to create additional color contrast levels.

“Spatial dithering” is a method to produce additional colors by varyingthe individual colors making up the colored stimulus pattern. Much likeimpressionistic paintings, a patient's overall perception of the colorcontrast stimulus will comprise the diffusion of the color contrastlevels of the individual components of the stimulus pattern, i.e., thediffusion of the dots, squares, blobs, etc., within the pattern. Incomputer graphics, for example, spatial dithering is the use of two ormore different colors in a pattern creating a different, third, color.

Accordingly, in some aspects, the current devices, procedures, andmethods can utilize a similar “spatial dithering” method of presentingthe color stimulus by varying the color contrast of the individualpixels or areas making up the colored stimulus, wherein a singlecone-isolating color is presented as a stimulus pattern, area, or regionformed from, for example, dots, squares, blobs, etc., in varyingcontrast levels to control the overall perception of color contrast.This method produces additional perceivable color contrast levels of thesame color not creating additional colors through the use of differingcolors as in computer graphics. This method allows for many more colorcontrast levels to be achieved using off-the-shelf computers nototherwise capable producing or presenting such colors. The result is afiner presentation of cone contrast levels and a more precisemeasurement of a patient's change in color perception, resulting in amore sensitive instrument for earlier detection of disease, diseaseprogression and visual improvements from therapies, etc. These devices,procedures, and methods differ from pseudo-isochromatic color visiontests, which use random dot patterns of differing colors (e.g., red,green) to determine if a patient can distinguish between them, in thatthe same cone-isolating colors are presented in differing color contrastlevels to create additional contrast levels to determine the thresholdof specific cone types.

In aspects of such procedures, a stimulus may be presented as aplurality of colored dots of the same cone-isolating color (red, green,or blue) or, alternatively, cone-isolating color plus grey. The actualcolor contrast level is controlled by varying the color contrast of theindividual dots making up the stimulus, for example color contrast 1,color contrast 2, and/or grey, where color contrast 1 and color contrast2 are both contrast levels of the same color. The background is grey. Byvarying the color contrast over 2 or more contrast levels, theperception of the color contrast can be further controlled. The size ofthe color contrast dots may vary within the stimulus to further refinethe color contrast level achieved. The overall grouping of the pluralityof dots may represent a letter, an image, or can simply comprise acolored section area or region. The colored stimulus may be presented asa single stimulus or in a forced choice pattern as defined above.Presentations may be two-dimensional or multi-dimensional. Based on apatient's correct or incorrect response, the color contrast level of thesome or all of the dots making up the stimulus will decrease orincrease. The patient's threshold for that cone-isolating color may thenbe determined by the lowest color contrast image the patient can see forthat color. The test continues until the patient's threshold for eachcolor is determined and each cone-isolating color (red, green, and blue)is repeated in the same fashion for each eye.

In some further aspects, temporal dithering can also be utilized forpurposes of creating additional color contrast levels. According to thismethod, additional color contrast levels can be created by rapidlychanging the color contrast (cc) level of a same cone-isolation color(red, green, or blue) of a single stimulus. In such cases, colors can berapidly presented in a pattern such as: cc1, cc2, cc1, cc2, where, forexample, cc1 is equivalent to color 1 at contrast level 1 and cc2 iscolor 1 at contrast level 2, and the rapid change from cc1 to cc2 isimperceptible to a patient. The underlying effect, however, is that theperceivable color contrast level is a diffusion of the color contrastlevels presented. Alternatively, additional presentation patterns couldfurther control the perceived color contrast levels. For example, cc1,cc1, cc2, cc1, cc1, cc2, would create a different color contrast levelthan the previous example. In this way, many additional color contrastlevels can be presented using off-the-shelf computer technology.Accordingly, where such testing procedures are utilized, the colorcontrast level of the colored section can be increased or decreasedbased on a patient's response. Much like the previous examples, the grey“background” color remains constant and the patient's threshold for aparticular cone-isolating color is determined by the lowest colorcontrast image the patient can see for that color. Each cone-isolatingcolor (red, green, and blue) is repeated in the same fashion. The testcontinues until the patient's threshold for each color is determined andeach cone-isolating color (red, green, and blue) is repeated in the samefashion for each eye. In such cases, the colored stimulus can bepresented as a single stimulus or in a forced choice pattern asdescribed above. Also, presentations may be two-dimensional ormulti-dimensional.

In further aspects, remote monitoring of patients is becoming more andmore necessary as diabetes and eye disease continues to riseexponentially while the number of ophthalmologists is declining and onlya portion of optometry is medical. Additionally, scheduling an eye examweeks or months in advance can allow critical eye disease to advance andcause irreversible vision loss. Moreover, many older people are fearfulof contracting COVID-19, making them less likely to schedule regularexams. Hence, there is a great need for an affordable, at-home or othertele-health device that can monitor disease progression in between eyeexams. Computer tablets with good display characteristics capable ofproducing precise color contrast levels are expensive and can easily bedropped or broken such that alternative testing devices are needed. Inaccordance therewith, in some aspects, an alternative testing device forat-home or tele-health use can include a smartphone, smart watch, orcomputer-driven headset where color contrast stimuli may be presented as2 or 3-D images. Any of the above stimuli described stimuli may bepresented in sections. And, while the number of sections can vary, apreferred method is to present 4-6 sections in a ring format to createenough differentiation in eye movement to utilize eye tracking. In suchprocedures, a patient can be instructed to view the colored stimulus. Ifusing a headset, eye tracking software monitors the patient's gaze anddetermines whether the patient has identified the colored stimuli. Ifthe patient gazes at the colored stimulus for a predetermined period oftime, for example, the response may be recorded as correct. By contrast,if the patient looks away from the colored stimulus for a predeterminednumber of seconds or directs his gazes inconsistently at both thecolored stimulus and grey area, the response may be recorded asincorrect. In an alternate presentation, where voice recognitionsoftware is utilized, a patient can respond via a verbal command. Basedon a patient's correct or incorrect response, the color contrast levelof the colored section can be decreased or increased. Much like theprevious examples, the grey “background” color contrast level remainsconstant. The patient's threshold for that cone-isolating color isdetermined by the lowest color contrast stimulus the patient can see forthat color. The test continues until the patient's threshold for eachcolor is determined and each cone-isolating color (red, green, and blue)is repeated in the same fashion for each eye.

Turning now to FIGS. 27A-31B, which illustrate examples of thepreviously discussed “Forced Choice” type testing procedures, the use ofsine wave gratings, as well as the use of spatial and temporal ditheringfor purposes of assessing cone contrast levels in a patient.

FIGS. 27A-27C illustrate an example of one type of “Forced Choice” colorcontrast level testing procedure. As shown in FIG. 27A, during suchtest, a first testing screen 610 comprising a testing field 612including a first color at a first contrast level in a first sub-region614 and a second color (grey) at a first contrast level in a secondsub-region 616 may be displayed to a patient. As compared to CCT testingprocedures utilizing characters requiring visual acuity, it is seen thatthe testing field 612, and first sub-region 614 and second sub-region616 thereof, are configured to encompass a large or substantial portionof the testing screen 610 such that patients with low visual acuityand/or individuals performing testing on smaller devices, such as smartphones, may readily perceive sub-region 614. In accordance therewith,testing field 612 can utilize a quadrant-type system wherein a firstcolor for which color contrast level is to be tested (red, green orblue) is randomly presented in a first one of four quadrants, and thesecond color (grey) is presented in the remaining three quadrants of thetesting field 612. As shown in FIG. 27A, the first color is shown asoccupying the lower right quadrant and the second color is shown asoccupying the remaining quadrants. Hence, where the first contrast levelof the first color in the first region 614 is perceived by a patient tooccupy the lower right quadrant of testing field 612, the patient mayprovide an appropriate input thereof by touching the touchscreen at thatposition, by inputting a signal via a directional-type touchpad or inputdevice, by providing an appropriate voice indication thereof to acomputer executing voice recognition software, or such input may beprovided by monitoring and/or recording the patient's eye movements orgaze, which is input to a computer executing eye-tracking software.Where a patient is unable to ascertain the first color presented, apatient may provide a “pass”—type input by means of a touchscreen icon(not shown), by inputting a signal via a directional-type touchpad orinput device, by providing a voice indication thereof, or by monitoringand/or recording the patient's eye movements or gaze. Based on thepatient's correct or incorrect response, the color contrast level of thefirst color can be decreased or increased as appropriate and a new orrefreshed testing screen presented.

As shown in FIG. 27B, where a correct response is input by the patientor measured at testing screen 610, a new screen may be presented orrefreshed such that testing screen 620 displayed. As may be appreciated,testing screen 620 is similar to testing screen 610 in that it alsocomprises a quadrant-type system wherein the first color for which colorcontrast level is being tested (red, green or blue) is deliberately orrandomly presented in a first one of four quadrants, and the secondcolor (grey) is presented in the remaining three quadrants of thetesting field 622. However, as compared to testing screen 610, thecontrast level of the first color has been modified and the location ofthe first color has also been shifted to occupy sub-region 624 locatedat the upper right quadrant thereof and the second color (grey) hasshifted to occupy the remaining sub-regions of 626. That is, the firstcolor has shifted to occupy third sub-region 624 and the second colorhas shifted to occupy fourth sub-region 626. Additionally, as comparedto testing screen 610, the contrast level of the first color of thirdsub-region 624 has been changed to comprise a second contrast level thatis lower than that of first sub-region 614. Accordingly, where thesecond contrast level of the first color in the third sub-region 624 isperceived by a patient to occupy the upper right quadrant of testingfield 622, the patient may provide an appropriate input thereof bytouching the touchscreen at that position, by inputting a signal via adirectional-type touchpad or input device, by providing an appropriatevoice indication thereof, or such input may be provided by monitoringand/or recording the patient's eye movements or gaze and the use ofeye-tracking software. Where a patient is unable to ascertain the firstcolor, the patient may provide a “pass”-type input by means of atouchscreen icon (not shown), by inputting a signal via adirectional-type touchpad or input device, by providing a voiceindication thereof, or by monitoring and/or recording the patient's eyemovements or gaze. Based on the patient's correct or incorrect response,the color contrast level of the first color can be increased ordecreased, as appropriate and a new or refreshed testing screenpresented.

As shown in FIG. 27C, where a correct response is input by the patientor measured at testing screen 620, a new screen may be presented orrefreshed such that testing screen 630 displayed. As may be appreciated,testing screen 630 is similar to testing screens 610 and 620 in thatthey also comprise a quadrant-type system wherein the first color forwhich color contrast level is being tested (red, green or blue) isdeliberately or randomly presented in a first one of four quadrants, andthe second color (grey) is presented in the remaining three quadrants ofthe testing field 632. However, as compared to testing screens 610 and620, the contrast level of the first color has been modified and thelocation of the first color has also shifted to occupy sub-region 634located at the upper left quadrant thereof and the second color hasshifted to occupy the remaining sub-regions 636. That is, the firstcolor has shifted to occupy fifth sub-region 634 and the second colorhas shifted to occupy sixth sub-region 636. Additionally, as compared totesting screens 610 and 620, the contrast level of the first color offifth sub-region 634 has been changed to comprise a third contrast levelthat is higher or lower that of the first and third sub-regions 614 and624 based on the patients correct or incorrect response. Accordingly,where the third contrast level of the first color in the fifthsub-region 634 is perceived by a patient to occupy the upper leftquadrant of testing field 632, the patient may provide an appropriateinput thereof by touching the touchscreen at that position, by inputtinga signal via a directional-type touchpad or input device, by providingan appropriate voice indication thereof, or such input may be providedby monitoring and/or recording the patient's eye movements or gaze andthe use of eye-tracking software. Where a patient is unable to ascertainthe first color, the patient may provide a “pass”-type input by means ofa touchscreen icon (not shown), by inputting a signal via adirectional-type touchpad or input device, by providing a voiceindication thereof, or by monitoring and/or recording the patient's eyemovements or gaze.

As may be appreciated, additional testing screens may be presented anddifferent contrast levels presented until the patient's threshold for aspecific color is determined. Upon completion of a specific color phasein the testing process, testing software will continue to the next colorphase for the tested eye. If all color phases have been completed forthe tested eye, testing software displays an eye selection screen andcontinues the testing process with the next eye to be tested. If allcolor phases for both eyes have been completed, the test process iscomplete. As may be appreciated, while the above primarily describesdecreasing contrast levels in the case of a correct response, one ormore first color contrast levels and their positions may be randomlypresented, or re-presented as needed, for example, in the case of apass-type input, a delay in providing an input, or lack of an inputwithin a specified time limit.

As shown in FIGS. 28A-28C, another example of a contrast level testingprocedure is illustrated, which is similar to the procedure of FIGS.27A-27C, but rather than utilizing quadrants, such procedure utilizes anarea or region, e.g., (e.g., large circles) corresponding to apositional location of the display screen that may be readily perceivedby individuals with low visual acuity. As may be appreciated by suchfigures, the areas or regions are displayed to the testing screen suchthat they are disposed at a plurality of readily identifiable testingscreen positional locations, for example, at upper, lower, leftward orrightward positions. To this end, as shown in FIG. 28A, during a test, afirst testing screen 710 comprising a testing field 712 including firstcolor at a first contrast level in a first sub-region 714 and a secondcolor (grey) in a second sub-region 616 may be displayed to a patient.As compared to CCT testing procedures utilizing characters requiringboth color vision and visual acuity, it is seen that the testing field712, and first sub-region 714 and second sub-region 716 thereof, areconfigured to encompass a large, or substantial, portion of the testingscreen 710 such that patients with low visual acuity and/or individualsperforming testing on smaller devices, such as smart phones, may readilyperceive sub-regions 714 and 716. In accordance therewith, testing field712 can utilize an orientation system wherein a first color for whichcolor contrast level is to be tested (red, green or blue) is randomlypresented in a first one of an upper, lower, leftward or rightwardscreen position and the second color (grey) is presented in theremainder of the testing field 712. As shown in FIG. 28A, the firstcolor is shown as occupying the rightward screen position and the secondcolor is shown as occupying the remainder of the testing field 712,i.e., second sub-region 716. Hence, where the first contrast level ofthe first color in the first region 714 is perceived by a patient tooccupy the rightward position of testing field 712, the patient mayprovide an appropriate input thereof by touching the touchscreen at thatposition, by inputting a signal via a directional-type touchpad or inputdevice, by providing an appropriate voice indication thereof, or suchinput may be provided by monitoring, by recording the patient's eyemovements or gaze via the use of eye-tracking software and/or patient'shand gestures via the use of hand-gesture software. Where a patient isunable to ascertain the first color, a patient may provide a “pass”-typeinput by means of a touchscreen icon (not shown), by inputting a signalvia a touchpad or input device, by providing a voice indication thereof,by monitoring and/or recording the patient's eye movements or gazeand/or monitoring and/or recording the patient's hand gestures. Based onthe patient's correct or incorrect response, the color contrast level ofthe first color can be decreased or increased, as appropriate and a newor refreshed testing screen presented.

As shown in FIG. 28B, where a correct response is input by the patientor measured at testing screen 710, a new screen may be presented orrefreshed such that testing screen 720 displayed. As may be appreciated,testing screen 720 is similar to testing screen 710 in that it alsocomprises a positional-type system wherein the first color for whichcolor contrast level is being tested (red, green or blue) is randomly ordeliberately presented in a first one of four screen positions, and thesecond color (grey) is presented in the remainder of the testing filed722. However, as compared to testing screen 710, the contrast level ofthe first color has been modified and the location of the first colorhas also shifted to occupy sub-region 724 located at the upper positionthereof and the second color has shifted to occupy sub-region 726. Thatis, the first color has shifted to occupy third sub-region 724 and thesecond color has shifted to occupy fourth sub-region 726. Additionally,as compared to testing screen 710, the contrast level of the first colorof third sub-region 724 has been changed to comprise a second contrastlevel that is lower that of first sub-region 714. Accordingly, where thesecond contrast level of the first color in the third sub-region 724 isperceived by a patient to occupy the upper position of testing field722, the patient may provide an appropriate input thereof by touchingthe touchscreen at that position, by inputting a signal via adirectional-type touchpad or input device, by providing an appropriatevoice indication thereof, or such input may be provided by monitoringand/or recording the patient's eye movements or gaze and the use ofeye-tracking software. Where a patient is unable to ascertain the firstcolor, the patient may provide a “pass”-type input by means of atouchscreen icon (not shown), by inputting a signal via a touchpad orinput device, by providing a voice indication thereof, or by monitoringand/or recording the patient's eye movements or gaze. Based on thepatient's correct or incorrect response, the color contrast level of thefirst color can be decreased or increased, as appropriate and a new orrefreshed testing screen presented.

As shown in FIG. 28C, where a correct response is input by the patientor detected at testing screen 720, a new screen may be presented orrefreshed such that testing screen 730 displayed. As may be appreciated,testing screen 730 is similar to testing screens 710 and 720 in that italso comprises a positional-type system wherein the first color forwhich color contrast level is being tested (red, green or blue) israndomly or deliberately presented in a first one of four positions, andthe second color (grey) is presented in the remainder of testing field732. However, as compared to testing screens 710 and 720, the contrastlevel of the first color has been modified and the location of the firstcolor has also shifted to occupy sub-region 734 located at the leftwardposition thereof and the second color has shifted to occupy theremaining sub-region 736. That is, the first color has shifted to occupyfifth sub-region 734 and the second color has shifted to occupy sixthsub-region 736. Additionally, as compared to testing screens 710 and720, the contrast level of the first color of fifth sub-region 734 hasbeen changed to comprise a third contrast level that is higher or lowerthat of the first and third sub-regions 714 and 724. Accordingly, wherethe third contrast level of the first color in the fifth sub-region 734is perceived by a patient to occupy the leftward position of testingfield 732, the patient may provide an appropriate input thereof bytouching the touchscreen at that position, by inputting a signal via adirectional-type touchpad or input device, by providing an appropriatevoice indication thereof, or such input may be provided by monitoringand/or recording the patient's eye movements or gaze and the use ofeye-tracking software, or by an appropriate hand gesture thereof, orsuch input may be provided by monitoring and/or recording the patient'shand gestures and the use of hand-gesture software. Where a patient isunable to ascertain the first color, the patient may provide a“pass”-type input by means of a touchscreen icon (not shown), byinputting a signal via a touchpad or input device, by providing a voiceindication thereof, by monitoring and/or recording the patient's eyemovements or gaze, or by monitoring and/or recording the patient's handgesture.

As may be appreciated, additional testing screens may be presented anddifferent contrast levels presented until the patient's threshold for aspecific color is determined. Upon completion of a specific color phasein the testing process, testing software will continue to the next colorphase for the tested eye. If all color phases have been completed forthe tested eye, testing software can display an eye selection screen andcontinue the testing process with the next eye to be tested. If allcolor phases for both eyes have been completed, the test process iscomplete. As may be appreciated, while the above primarily describesdecreasing contrast levels in the case of a correct response, increasingcontrast levels are presented in the case of an incorrect response,including a pass-type input, a delay in providing an input, or lack ofan input. In addition, one or more first color contrast levels and theirpositions may be randomly presented, or re-presented. Additionally,while the above examples describe a total of four quadrants or screenpositions, it should be appreciated that the subject matter is notparticularly limited to a total four quadrants or four screen positions,and the number of sub-regions or positions may be higher or lower.

Referring now to FIGS. 29A-29D, in addition to the above use ofquadrants and the screen position of sub-regions, the quadrants andsub-regions or areas can be configured to utilize sine wave gratings forpurposes of assessing cone contrast sensitivity.

As shown in FIG. 29A, during a test, a first testing screen 810comprising a testing field 812 including a linear sine wave grating of afirst color at a first contrast level in a first sub-region 814 and asecond color (grey) at a set contrast level in a second sub-region 816may be displayed to a patient. As compared to CCT testing proceduresutilizing characters requiring both color vision and visual acuity, itis seen that the testing field 812, and first sub-region 814 and secondsub-region 816 thereof, are configured to encompass a large, orsubstantial, portion of the testing screen 810 such that patients withlow visual acuity and/or individuals performing testing on smallerdevices, such as smart phones, may readily perceive sub-regions 814 and816. In accordance therewith, testing field 812 can utilize anorientation system wherein a first color for which color contrast levelis to be tested (red, green or blue) is randomly presented in a firstone of an upper, lower, leftward or rightward screen position and thesecond color is presented in the remainder of the testing field 812. Asshown in FIG. 29A, the first color is shown as occupying the rightwardscreen position and the second color is shown as occupying the remainderof the testing field 812, i.e., second sub-region 816. Hence, where thefirst contrast level of the first color in the first region 814 isperceived by a patient to occupy the rightward position of testing field812, the patient may provide an appropriate input thereof by touchingthe touchscreen at that position, by inputting a signal via adirectional-type touchpad or input device, by providing an appropriatevoice indication thereof, or such input may be provided by monitoringand/or recording the patient's eye movements or gaze via the use ofeye-tracking software or by providing an appropriate hand gestureindication thereof, or such input may be provided by monitoring and/orrecording the patient's hand gestures. Where a patient is unable toascertain the first color, a patient may provide a “pass”-type input bymeans of a touchscreen icon (not shown), by inputting a signal via atouchpad or input device, by providing a voice indication thereof, bymonitoring and/or recording the patient's eye movements or gaze, or bymonitoring and/or recording the patient's hand gestures. Based on thepatient's correct or incorrect response, the color contrast level of thefirst color can be decreased or increased, as appropriate and a new orrefreshed testing screen presented.

As shown in FIG. 29B, where a correct response is input by the patientor measured at testing screen 810, a new screen may be presented orrefreshed such that testing screen 820 displayed. As may be appreciated,testing screen 820 is similar to testing screen 810 in that it alsocomprises a positional-type system wherein the first color for whichcolor contrast level is being tested (red, green or blue) is randomly ordeliberately presented in a first one of several screen positions, andthe second color (grey) is presented in the remainder of the testingfield 822. However, as compared to testing screen 810, the contrastlevel of the first color has been modified and the location of the firstcolor has also shifted to occupy sub-region 824 located at the upperposition thereof and the second color has shifted to occupy sub-region826. That is, the first color has shifted to occupy third sub-region 824and the second color has shifted to occupy fourth sub-region 826.Additionally, as compared to testing screen 810, the contrast level ofthe first color of third sub-region 824 has been changed to comprise asecond contrast level that is higher or lower that of first sub-region814 based on the patient's correct or incorrect response. Accordingly,where the second contrast level of the first color in the thirdsub-region 824 is perceived by a patient to occupy the upper position oftesting field 822, the patient may provide an appropriate input thereofby touching the touchscreen at that position, by inputting a signal viaa directional-type touchpad or input device, by providing an appropriatevoice indication thereof, or such input may be provided by monitoringand/or recording the patient's eye movements or gaze and the use ofeye-tracking software or by providing an appropriate hand gestureindication thereof, or such input may be provided by monitoring and/orrecording the patient's hand gestures and the use of hand-gesturesoftware. Where a patient is unable to ascertain the first color, thepatient may provide a “pass”-type input by means of a touchscreen icon(not shown), by inputting a signal via a touchpad or input device, byproviding a voice indication thereof, by monitoring and/or recording thepatient's eye movements or gaze or by monitoring and/or recording thepatient's hand gestures. Based on the patient's correct or incorrectresponse, the color contrast level of the first color can be decreasedor increased, as appropriate and a new or refreshed testing screenpresented.

As shown in FIG. 29C, where a correct response is input by the patientor measured at testing screen 820, a new screen may be presented orrefreshed such that testing screen 830 displayed. As may be appreciated,testing screen 830 is similar to testing screens 810 and 820 in that italso comprises a positional-type system wherein the first color forwhich color contrast level is being tested (red, green or blue) israndomly or deliberately presented in a first one of several positions,and the second color (grey) is presented in the remainder of testingfield 832. However, as compared to testing screens 810 and 820, thecontrast level of the first color has been modified and the location ofthe first color has also shifted to occupy sub-region 834 located at theleftward position thereof and the second color has shifted to occupy theremaining sub-region 836. That is, the first color has shifted to occupyfifth sub-region 834 and the second color has shifted to occupy sixthsub-region 836. Additionally, as compared to testing screens 810 and820, the contrast level of the first color of fifth sub-region 834 hasbeen changed to comprise a third contrast level that is higher or lower,based on the patient's response, that of the first and third sub-regions814 and 824. Accordingly, where the third contrast level of the firstcolor in the fifth sub-region 834 is perceived by a patient to occupythe leftward position of testing field 832, the patient may provide anappropriate input thereof by touching the touchscreen at that position,by inputting a signal via a directional-type touchpad or input device,by providing an appropriate voice indication thereof, or such input maybe provided by monitoring and/or recording the patient's eye movementsor gaze and the use of eye-tracking software, or by providing anappropriate hand gesture indication thereof, or such input may beprovided by monitoring and/or recording the patient's hand gestures andthe use of hand-gesture software. Where a patient is unable to ascertainthe first color, the patient may provide a “pass”-type input by means ofa touchscreen icon (not shown), by inputting a signal via a touchpad orinput device, by providing a voice indication thereof, by monitoringand/or recording the patient's eye movements or gaze or monitoringand/or recording the patient's hand gestures.

As shown in FIG. 29D, testing procedures utilizing sine wave gratingscan also be configured to comprise circular type gratings and applysimilar methods set forth relative to FIGS. 29A-29C. Hence, testingscreen 840 is shown as including a testing field 842 including firstsub-region 844 and second sub-region 846, wherein first sub-region isshown as occupying a lower screen position, and second sub-region 846occupying the remainder of field 846.

As may be appreciated, additional testing screens may be presented anddifferent contrast levels presented until the patient's threshold for aspecific color is determined. Upon completion of a specific color phasein the testing process, testing software will continue to the next colorphase for the tested eye. If all color phases have been completed forthe tested eye, testing software displays an eye selection screen andcontinue the testing process with the next eye to be tested. If allcolor phases for both eyes have been completed, the test process iscomplete. As may be appreciated, while the above primarily describesdecreasing contrast levels in the case of a correct response, one ormore first color contrast levels and their positions may be randomlypresented, or re-presented as needed, for example, in the case of apass-type input, a delay in providing an input, or lack of an input.Additionally, while the above examples describe a total of fourquadrants or screen positions, it should be appreciated that the subjectmatter is not particularly limited to a total four quadrants or fourscreen positions, and the number of sub-regions or positions may behigher or lower.

Referring now to FIGS. 30A-30D, in addition to the above use ofquadrants and the screen position of sub-regions, the quadrants andsub-regions or areas can be configured to utilize spatial or temporaldithering for purposes of assessing cone contrast sensitivity.

As shown in FIG. 30A, during a test, a first testing screen 910comprising a testing field 912 including a first color at a firstcontrast level in a first sub-region 914 provided via the use of spatialor temporal dithering, and a second color (grey) at a first contrastlevel in a second sub-region 916 may be displayed to a patient. Ascompared to CCT testing procedures utilizing characters requiring bothcolor vision and visual acuity, it is seen that the testing field 912,and first sub-region 914 and second sub-region 916 thereof, areconfigured to encompass a large, or substantial, portion of the testingscreen 910 such that patients with low visual acuity and/or individualsperforming testing on smaller devices, such as smart phones, may readilyperceive sub-regions 914 and 916. In accordance therewith, testing field912 can utilize an orientation system wherein a first color for whichcolor contrast level is to be tested (red, green or blue) is randomly ordeliberately presented in a first one of an upper, lower, leftward orrightward screen position and the second color is presented in theremainder of the testing field 912. As shown in FIG. 30A, the firstcolor is shown as occupying the lower screen position and the secondcolor is shown as occupying the remainder of the testing field 912,i.e., second sub-region 916. Hence, where the first contrast level ofthe first color in the first region 914 is perceived by a patient tooccupy the lower position of testing field 912, the patient may providean appropriate input thereof by touching the touchscreen at thatposition, by inputting a signal via a directional-type touchpad or inputdevice, by providing an appropriate voice indication thereof, or suchinput may be provided by monitoring and/or recording the patient's eyemovements or gaze via the use of eye-tracking software, or by providingan appropriate hand gesture indication thereof, or such input may beprovided by monitoring and/or recording the patient's hand gestures viathe use of hand-gesture software. Where a patient is unable to ascertainthe first color, a patient may provide a “pass”-type input by means of atouchscreen icon (not shown), by inputting a signal via a touchpad orinput device, by providing a voice indication thereof, by monitoringand/or recording the patient's eye movements or gaze, or by monitoringand/or recording the patient's hand gestures. Based on the patient'scorrect or incorrect response, the color contrast level of the firstcolor can be decreased or increased, as appropriate and a new orrefreshed testing screen presented.

As shown in FIG. 30B, where a correct response is input by the patientor measured at testing screen 910, a new screen may be presented orrefreshed such that testing screen 920 displayed. As may be appreciated,testing screen 920 is similar to testing screen 910 in that it alsocomprises a positional-type system wherein the first color for whichcolor contrast level is being tested (red, green or blue) is randomly ordeliberately presented in a first one of four screen positions, and thesecond color (grey) is presented in the remainder of the testing field922. However, as compared to testing screen 910, the contrast level ofthe first color has been modified and the location of the first colorhas also shifted to occupy sub-region 924 located at the leftwardposition thereof and the second color has shifted to occupy sub-region926. That is, the first color has shifted to occupy third sub-region 924and the second color has shifted to occupy fourth sub-region 926.Additionally, as compared to testing screen 910, and by the processes ofspatial or temporal dithering, the contrast level of the first color ofthird sub-region 924 has been changed to comprise a second contrastlevel that is lower that of first sub-region 914. Accordingly, where thesecond contrast level of the first color in the third sub-region 924 isperceived by a patient to occupy the leftward position of testing field922, the patient may provide an appropriate input thereof by touchingthe touchscreen at that position, by inputting a signal via adirectional-type touchpad or input device, by providing an appropriatevoice indication thereof, or such input may be provided by monitoringand/or recording the patient's eye movements or gaze and the use ofeye-tracking software, or by providing an appropriate hand gesturethereof, or such input may be provided by monitoring and/or recordingthe patient's had gestures and the use of hand-gesture software. Where apatient is unable to ascertain the first color, the patient may providea “pass”-type input by means of a touchscreen icon (not shown), byinputting a signal via a touchpad or input device, by providing a voiceindication thereof, by monitoring and/or recording the patient's eyemovements or gaze, or by monitoring and/or recording the patient's handgestures. Based on the patient's correct or incorrect response, thecolor contrast level of the first color can be decreased or increased,as appropriate and a new or refreshed testing screen presented.

As shown in FIG. 30C, where a correct response is input by the patientor measured at testing screen 920, a new screen may be presented orrefreshed such that testing screen 930 displayed. As may be appreciated,testing screen 930 is similar to testing screens 910 and 920 in that italso comprises a positional-type system wherein the first color forwhich color contrast level is being tested (red, green or blue) israndomly or deliberately presented in a first one of four positions, andthe second color (grey) is presented in the remainder of testing field932. However, as compared to testing screens 910 and 920, the contrastlevel of the first color has been modified by spatial or temporaldithering processes and the location of the first color has also shiftedto occupy sub-region 934 located at the rightward position thereof andthe second color has shifted to occupy the remaining sub-region 936.That is, the first color has shifted to occupy fifth sub-region 934 andthe second color has shifted to occupy sixth sub-region 936.Additionally, as compared to testing screens 910 and 920, the contrastlevel of the first color of fifth sub-region 934 has been changed tocomprise a third contrast level that is lower that of the first andthird sub-regions 914 and 924. Accordingly, where the third contrastlevel of the first color in the fifth sub-region 934 is perceived by apatient to occupy the rightward position of testing field 932, thepatient may provide an appropriate input thereof by touching thetouchscreen at that position, by inputting a signal via adirectional-type touchpad or input device, by providing an appropriatevoice indication thereof, or such input may be provided by monitoringand/or recording the patient's eye movements or gaze and the use ofeye-tracking software, or by providing an appropriate hand gestureindication thereof, or such input may be provided by monitoring and/orrecording the patient's hand gestures and the use of hand-gesturesoftware. Where a patient is unable to ascertain the first color, thepatient may provide a “pass”-type input by means of a touchscreen icon(not shown), by inputting a signal via a touchpad or input device, byproviding a voice indication thereof, or by monitoring and/or recordingthe patient's eye movements or gaze.

As may be appreciated, additional testing screens may be presented anddifferent contrast levels presented until the patient's threshold for aspecific color is determined. Upon completion of a specific color phasein the testing process, testing software will continue to the next colorphase for the tested eye. If all color phases have been completed forthe tested eye, testing software displays an eye selection screen andcontinues the testing process with the next eye to be tested. If allcolor phases for both eyes have been completed, the test process iscomplete. As may be appreciated, while the above primarily describesdecreasing contrast levels in the case of a correct response, one ormore first color contrast levels and their positions may be randomlypresented, or re-presented as needed, for example, in the case of apass-type input, a delay in providing an input, or lack of an input.Additionally, while the above examples describe a total of fourquadrants or screen positions, it should be appreciated that the subjectmatter is not particularly limited to a total four quadrants or fourscreen positions, and the number of sub-regions or positions may behigher or lower.

Referring now to FIGS. 31A-31B, while the previously describedmethodologies, e.g., “Forced Choice” type testing procedures, sine wavegratings, and spatial and temporal dithering, all describe the use ofpresenting a plurality of testing screens and subsequent testing screenswherein a sub-area or sub-region of a color to be tested can bedeliberately or randomly presented in a different positional location onthe each testing screen that is displayed, a so-called “real-time”testing screen may also be utilized. In such “real-time” testing screen,the positional location of a sub-region for which a color contrast levelis to be tested can remain constant, but the contrast level of the firstcolor at that same position can be progressively incremented ordecremented in real-time, for example, to pass from being perceptible toimperceptible, or vice-versa. In such case, where a first colorsub-region passes from being perceptible to imperceptible, for example,a patient may provide an appropriate input thereof by touching atouchscreen at the position, by inputting a signal via touchpad or inputdevice, by providing an appropriate voice indication thereof, or suchinput may be provided by monitoring and/or recording the patient's eyemovements or gaze and the use of eye-tracking software, or by providingand appropriate hand gesture indication thereof, or such input may beprovided by monitoring and/or recording the patient's hand gestures andthe use of hand-gesture software. Where a patient is unable to ascertainthe first color, the patient may provide a “pass”-type input by means ofa touchscreen icon (not shown), by inputting a signal via a touchpad orinput device, by providing a voice indication thereof, by monitoringand/or recording the patient's eye movements or gaze, or by monitoringand/or recording the patient's hand gestures. In accordance with theabove, as shown in FIGS. 31A and 31B, testing screen 1010 comprisingtesting field 1012 including a first color at a first contrast level ina first sub-region 1014 can be progressively incrementally displayedaccording to one or more of the previously discussed procedures, e.g.,including but not limited to spatial or temporal dithering, and a secondcolor (grey) at a first contrast level in a second sub-region 1016 maybe displayed to a patient. As compared to CCT testing proceduresutilizing characters requiring both color vision and visual acuity, itis seen that the testing field 1012, and first sub-region 1014 andsecond sub-region 1016 thereof, are configured to encompass a large, orsubstantial, portion of the testing screen 1010 such that patients withlow visual acuity and/or individuals performing testing on smallerdevices, such as smart phones, may readily perceive sub-regions 1014 and1016. In accordance therewith, a first color for which color contrastlevel is to be tested (red, green or blue) can be progressivelypresented at, for example, a central position of testing field 1012 andthe second color (grey) presented at the remaining portions of thetesting field 1012. As may be appreciated from FIGS. 31A and 31B, thecolor contrast level of first sub-region 1014 is shown as beingprogressively desaturated from the higher contrast level shown in FIG.31A to the lower contrast shown in FIG. 31B. While not shown, duringsuch procedure, for example, as the contrast level of first region 1014is progressively decreased, it passes from being perceptible to beingimperceptible, wherein at such point a patient may provide anappropriate input to acknowledge that the first region 1014 is no longerperceptible. Of course, other previously discussed inputs may also beutilized.

FIGS. 32A-32B illustrate an example of another color contrast leveltesting procedure, wherein, for example, cone-isolating color contrastlevels may be presented in multiple quadrants at a time. In such tests,each quadrant can display a different color contrast level of a colorand a patient identifies which of the lowest contrast levels areperceptible. This type of test is believed to significantly speed up thetesting process as the patient can identify the lowest contrast quadrantthat is perceptible without having to navigate through a plurality ofscreens. The test typically proceeds at or around the patient's lowestcontrast level with repetitive presentations of either multiplequadrants or single presentations. In most cases, the color presented ineach quadrant can be the same, however, to increase the confidence ofthe response, one or more of the quadrants may be a background color(grey). If the patient selects a quadrant corresponding to thebackground color, the test can re-present the same color contrast levelsfor the color being tested in a randomized fashion before proceeding tothe next phase of testing, i.e., presenting a subsequent screen withquadrants or regions of a differing contrast. Where a patient is unableto perceive any of the quadrants or regions, the pass options discussedrelative to the previously discussed tests would be available. As shownin FIG. 32A, for example, during such test, a first testing screen 1100comprising a testing field 1112 including first sub-region 1114, secondsub-region 1116, third sub-region 1118, and fourth sub-region 1118 maybe presented to a patient. As compared to CCT testing proceduresutilizing characters requiring visual acuity, it is seen that thetesting field 1112, and first through fourth sub-regions 1114-1120, areconfigured to encompass a large or substantial portion of the testingscreen 1110 such that patients with low visual acuity and/or individualsperforming testing on smaller devices, such as smart phones, may readilyperceive sub-regions several sub-regions. In accordance therewith,testing field 1112 is shown as utilizing a quadrant-type system whereina first color for which color contrast level is to be tested (red, greenor blue) is deliberately or randomly presented at varying contrastlevels in each of the four quadrants. A second color (grey) may,optionally, be presented in one of the four quadrants of the testingfield 1112. As shown in FIG. 32A, the contrast levels of each ofsub-regions one through four vary relative to one another withsub-region 1120 having the highest contrast and sub-region 1118 havingthe lowest contrast thereof. Hence, where the lowest contrast level ofthe first color in sub-region 1118 is perceived by a patient to occupythe lower left quadrant of testing field 1118, the patient may providean appropriate input thereof by touching the touchscreen at thatposition, by inputting a signal via a directional-type touchpad or inputdevice, by providing an appropriate voice indication thereof to acomputer executing voice recognition software, or such input may beprovided by monitoring and/or recording the patient's eye movements orgaze, which is input to the computer executing eye-tracking software.Where a patient is unable to ascertain the first color presented, apatient may provide a “pass”—type input by means of a touchscreen icon(not shown), by inputting a signal via a directional-type touchpad orinput device, by providing a voice indication thereof, or by monitoringand/or recording the patient's eye movements or gaze. Based on thepatient's correct or incorrect response, the color contrast level of thefirst color can be decreased or increased as appropriate and a new orrefreshed testing screen presented.

As shown in FIG. 32B, where a correct response is input by the patientor measured at testing screen 1110, a new screen may be presented orrefreshed such that testing screen 1122 is displayed. As may beappreciated, testing screen 1122 is similar to testing screen 1110 inthat it also comprises a quadrant-type system wherein the first colorfor which color contrast level is being tested (red, green or blue) isdeliberately or randomly presented at different contrast levels in thefour quadrants. A second color (grey) may, optionally, be presented inone of the four quadrants of the testing field 1112. However, ascompared to testing screen 1110, the contrast level of sub-regions onethrough four have been modified and/or rearranged relative to screen1110, and the contrast of the sub-regions of screen 1122 vary relativeto one another with sub-region 1120 having the highest contrast andsub-region 1118 having the lowest contrast thereof. Hence, where thelowest contrast level of the first color in sub-region 1118 is perceivedby a patient to occupy the lower left quadrant of testing field 1118,the patient may provide an appropriate input thereof by touching thetouchscreen at that position, by inputting a signal via adirectional-type touchpad or input device, by providing an appropriatevoice indication thereof to a computer executing voice recognitionsoftware, or such input may be provided by monitoring and/or recordingthe patient's eye movements or gaze, which is input to the computerexecuting eye-tracking software. Where a patient is unable to ascertainthe first color presented, a patient may provide a “pass”—type input bymeans of a touchscreen icon (not shown), by inputting a signal via adirectional-type touchpad or input device, by providing a voiceindication thereof, or by monitoring and/or recording the patient's eyemovements or gaze. Based on the patient's correct or incorrect response,the color contrast level of the first color can be decreased orincreased as appropriate and a new or refreshed testing screenpresented.

As may be appreciated, different contrast levels are progressivelypresented until the patient's threshold for a specific color isdetermined. Upon completion of a specific color phase in the testingprocess, testing software will continue to the next color phase for thetested eye. If all color phases have been completed for the tested eye,testing software displays an eye selection screen and continue thetesting process with the next eye to be tested. If all color phases forboth eyes have been completed, the test process is complete.

Currently, computerized color vision tests require eye careprofessionals to control the lighting in the testing environment,specifically creating a darkened room environment. Even with the adventof mobile testing equipment, such as tablet-based solutions, suchdevices often require a dedicated space, as well as technician time, inorder to conduct each test. Recent technological developments in virtualand augmented reality computerized headsets address this issue bycreating the proper environment within the headset without the need foraltered room lighting, technician monitoring, or dedicated space. Thatis, a computerized headset can wrap around a patient's head, blockingcompletely, or in part, light to be received by the eye, thereforeallowing the patient to take a test independent of a specific roomenvironment. One such computerized augmented reality headset can usered, green, and blue LED lights in combination to create the desiredfinal color/contrast image, similar to how a LCD monitor utilizes LEDlight to produce red, green, and blue colors to create the desiredcolored image. An example of this type of headset is the Magic Leap 1headset, currently commercially available from Magic Leap of Plantation,Florida. Other types of headsets can also utilize smartphones forpurposes of producing appropriate colored images.

Despite the differences between the use of a computerized headset and anLCD monitor with regard to the manner by which color images reach apatient's eye, the presented stimulus, as well as the calibration and/ormethods to determine the exact color contrast levels, remain similar.

In the case of the use of a computerized headset, because the use of aheadset is entirely a patient experience, test results may be stored ordisplayed differently as compared to a display screen of a traditionaldesktop computer or tablet, for example. In either a traditionalcomputer or headset scenario, test results may be stored on the localheadset computer, attached computer, e.g., utilizing Bluetooth or othermeans of communication, or in a cloud-based storage area. Where testresults are displayed, however, are dependent on the type of deviceutilized.

In the case of the desktop computer display, for example, the displayitself is visible to the technician and physician. This makes itpractical for the results to be stored locally on the device andsubsequently store the results in the patient's electronic healthrecord, and/or in a cloud-based storage area. Exam and progressionreports can be generated by the technician and/or doctor on the deviceitself for the doctor to interpret results and review with the patient.

In the case of the headset, however, because complete test resultsrequire physician interpretation, they may not be displayed on theheadset. Simplified test results, such as pass/fail or a message such as“test result indicate you should contact your doctor”, may be displayedon the headset for the patient, especially in an at-home application.Complete test results, needing interpretation by a physician, can betransferred, generated, and displayed on a separate computer, e.g., bywireless, wired, or physical transfer of such data from the headset tothe separate computer. Cone Contrast software may reside on a headsetfor calibration, test presentation, data storage, and limited reporting.Cone Contrast software could also reside on the separate computer fordata storage and full reporting and progression analysis, for example.

An additional difference between the use of a headset and a traditionaldesktop computer device, for example, is the need for and/or ease ofrecalibration. That is, owing to differences in environmental lightconditions and because changes can be readily or inadvertently made to atraditional desktop computer, such changes can affect the displaycharacteristics and the resultant test results. Recalibration is oftennecessary to ensure accurate, repeatable results. In the case of aheadset, however, because environmental light conditions are not as muchof a factor and/or the calibration controls of a headset can be moredifficult to access, the ability of a user or operating system toinadvertently negatively affect the display characteristics is reduced,therefore also reducing or eliminating the need for recalibration.

A further difference between a headset and traditional desktop computerdevice, for example, is the type of input device which can be utilized,as well as the number of available input choices/responses. The type ofinput device and number of choices/responses is primarily driven basedupon whether a patient can view the input device while taking the test.In the case of the traditional desktop computer, in which the patientcan see the display or a response pad, a wide variety of input devicescan be used, including a touchscreen, a mouse, a larger 2-handedresponse pad, etc. In the case of a headset, however, input devices needto account for the fact that the patient will not be able to see his/herhands while taking the test and/or see a particular input on atraditional input device. Hence, in the case of a headset, input optionsmay include voice recognition, eye tracking, or hand gestures toindicate the position or orientation of a color object, a wired orwireless hand-held response device.

In the case of the use of a headset, voice recognition, hand gesturing,or an input device that is capable of fitting in one hand, utilizingwireless communications, and including a limited number of choices thatcould be identified by feel alone are preferred methods of patientcommunication. For example, the input device may incorporate a 4-buttonhand-held wireless remote controller in which the patient uses his/herthumb to select the up, down, left, and right buttons to indicate theorientation of the colored regions, images, letters, symbols, etc.Alternatively, the input device may have a single button correspondingto a “yes” response indicating the patient was capable of viewing animage. A “no” or “pass” button could also be included to indicate thatno image was capable of being viewed.

Cone Contrast objects, such as letters, numbers, symbols, regions, dots,blobs, sine gratings, and other previously discussed objects, etc., canbe presented for each cone-type, red, green, and blue. Cone contrastobjects can be presented at different cone contrast levels for a setduration. In accordance therewith, a patient can be asked, for example,to respond as to whether he/she can view a colored object in the centerof a screen, the orientation of the object, or the position the objectoccupies within the screen, e.g., upward, downward, leftward, orrightward, for example.

The limited-response hand-held controller and swiping method ofresponse, however, increases the probability of “guessing” the correctanswer to 25% or 50% depending on the actual configuration. To addressthe high probability of error, a test algorithm must incorporate amethod for detecting likely problems. Methods such as AI or learningalgorithms, that prompt further testing upon incorrect responses toperiodic presentations of “blank” or sub-threshold presentations, may beutilized. Alternatively, additional presentations at the patient'sthreshold for each color—red, green, and blue as a validation step maybe used.

Incorrect answers at any cone contrast level can trigger additionaltesting pertaining to that cone contrast level. If the patient does notrespond to any cone contrast object above human threshold, that conecontrast level, as well as the level above, are further tested, similarto algorithms previously discussed. If the patient responds to a blankobject, the lowest 2 cone contrast levels, for example, as well asadditional sub-threshold or blank objects, can be tested to determinethe patient's threshold. As previously described, testing can end at thelowest cone contrast level in which 2 or more, or 3 out of 5 objects arecorrectly identified, for example. Scores can be calculated based on thelowest cone contrast level passed and/or number of correct responses.The amount of time required for the patient to respond to the stimulusmay also be recorded. In alternate scoring, response time may be used inthe scoring calculation to produce finer, more incremental scoring.

As shown in FIGS. 33 and 34 , an alternate presentation of cone contrasttesting includes cone contrast sequencing and is a method that issuitable to be used on the limited area of a smart phone. Becausesequencing is not dependent on letter or symbol recognition, iteliminates any visual acuity interference.

In accordance therewith, red, green and blue cone types can be presentedone at a time. Cone contrast shapes can be displayed in differing conecontrast levels for a single cone type against a grey background. In thetest, a patient must order the shapes from darkest to lightest. If thepatient cannot see a shape at a particular cone contrast level, he/shewill not select that shape to be sequenced. Duplicate cone contrastlevels as well as sub-threshold levels for normal color vision and/orblanks can be displayed to reduce the impact of guessing on the score,as well as test for super color vision for athletes or militarypersonnel.

Because cone contrast shapes may be perceived more or less easily thancharacters such as letters or numbers, for example, the actual conecontrast levels may differ from cone contrast levels in the letter orsymbol cone contrast presentations. For patients scores to be comparedover multiple instrument types, scoring may need to be normalized.

In some aspects, a selection tool, such as an arrow, can be displayed ona screen to guide selection, movement, and placement of a color contrastshape. The patient may tap the arrow to move it to the selection area ofthe screen. A second tap of the arrow can grab the shape to be moved.The shape can be altered to indicate to the patient that he/she hassuccessfully grabbed the shape. For example, a circle may be altered tobe larger or smaller, or be presented as oblong, or square-like. Once ashaped has been selected, the patient may move it to the repository partof the screen, or select a different shape. To sequence the shape, thepatient can move the shape to the outlined shape so that it is in orderfrom darkest to lightest as compare to all the shapes shown. Another tapcan release the shape, and the outline is filled in with the conecontrast color selected. The patient has been instructed to not select“blank” objects or objects that are not visible to them, even if thespacing of the objects make it appear that an object should be present.The repository part of the screen may or may not include an additionalplace for “blanks” to further challenge the patient's visible threshold.

Once this phase is completed, if a shape at any cone contrast level hasbeen incorrectly sequenced, the testing proceeds to Phase IL, in whichadditional color contrast shapes can be presented at the highest missedcontrast level, the cone contrast level above, the cone contrast levelbelow (if any), with additional sub-threshold and/or blank shapes, todetermine the threshold for that cone type. In addition, if a blankshape is selected in Phase I, it may be counted as incorrect and promptPhase II at the lowest correctly sequenced cone contrast level. Thethreshold level can be determined to be the lowest cone contrast levelin which 2 or more, or 3 out of 5 correct sequencing cone contrast leveloccurs, for example.

A score for each cone type can be calculated based on the number ofcorrectly sequenced shapes. Scores may be compared over time todetermine progression or improvement in cone function. Scores may bestored on the local device or in a cloud-based device and synchronizedto a referring doctor's EMR patient record.

Graphical and progression reports may be displayed on the patientdevice, or on the referring doctor's device. The referring doctor'sdevice could be a different type of instrument as compared to that usedby the patient, such as a smart phone versus a computer. Moreover, thereferring doctor's device may have a different presentation as thepatient's device, such as cone contrast letter presentation versus conecontrast sequencing.

Thus, it is seen that the objects of the present invention areefficiently obtained, although modifications and changes to theinvention should be readily apparent to those having ordinary skill inthe art, which modifications are intended to be within the spirit andscope of the invention as claimed. It also is understood that theforegoing description is illustrative of the present invention andshould not be considered as limiting. Therefore, other embodiments ofthe present invention are possible without departing from the spirit andscope of the present invention.

1. A method for administering a cone contrast color vision test to apatient using a computer, comprising the steps of: (a) simultaneouslydisplaying a first color at a first contrast level in a first region ofa display and a second color at a first contrast level in a secondregion of the display, which display is in communication with thecomputer; (b) receiving a first input signal from the patient via aninput device in communication with the computer, where the first inputsignal is indicative of whether the patient recognizes the first colordisplayed in the first region at the first contrast level; (c)displaying the first color at a second contrast level in a third regionof the display and the second color at a second contrast level in afourth region of the display, where the second contrast level of thefirst color is not equivalent to the first contrast level of the firstcolor; (d) receiving a second input signal from the patient via theinput device, where the second input signal is indicative of whether thepatient recognizes the first color displayed in the third region at thesecond contrast level; and, (e) assigning a score to the first andsecond input signals, the score related to a cone sensitivity of thepatient to the first color at the first and second contrast levels. 2.The method recited in claim 1, wherein the first color comprises one ofred, green, or blue cone-isolating colors, and the second color is grey.3. The method recited in claim 2, wherein the second contrast level ofthe first color differs from the first contrast level of the firstcolor.
 4. The method recited in claim 3, wherein when the first andsecond region are simultaneously displayed, the first region does notsimultaneously occupy the second region; and, when the third and fourthregion are simultaneously displayed, the third region does notsimultaneously occupy the fourth region.
 5. The method recited in claim4, wherein the first and third regions are displayed in one of an upper,leftward, rightward, or lower region of the display and a position ofthe first and third regions are randomly selected.
 6. The method recitedin claim 4, the first and third regions are displayed in a quadrant ofthe display and the quadrant of the first and third regions is randomlyselected.
 7. The method recited in claim 1, wherein the first and secondinput signals comprise at least one of a mouse click, touch input, avoice input, an eye tracking input, or a hand gesture input, the inputdevice is in communication with the computer
 8. The method recited inclaim 1, wherein at least one of the first and second contrast levels isset to a predetermined default value if there are no prior cone contrastcolor vision test records associated with the patient.
 9. The methodrecited in claim 8, wherein steps (a) through (f) are repeatedsequentially using values for the first and second contrast levels basedon the patient's cone contrast threshold level in a prior iteration ofthe cone contrast color vision test to determine a lowest conesensitivity of the patient.
 10. The method recited in claim 2, whereinthe first and second contrast levels of the first and third regions areprovided by: modifying saturation of the first color, modifyingsaturation of the first and second color simultaneously, spatialdithering, or temporal dithering.
 11. The method recited in claim 2,wherein the first and third regions comprise a sign wave grating patternformed from the first color presented between the first and second colorsaturation or intensity level, where the color saturation and/or spatialfrequency is increased or decreased based on the patient response untilthe patient reaches his contrast sensitivity threshold of the linear orconcentric circle sinusoidal gratings.
 12. The method recited in claim11, wherein the sign wave grating pattern is formed by varying thespatial frequency of the gratings formed from the first color presentedbetween the first and second color saturation or intensity level, wherethe color saturation and/or spatial frequency is increased or decreasedbased on the patient response until the patient reaches his contrastsensitivity threshold of the linear or concentric circle sinusoidalgratings.
 13. The method recited in claim 12, wherein the first andthird regions are disposed in one of an upper, leftward, rightward, orlower region of the display and a position of the first and thirdregions is randomly selected.
 14. The method recited in claim 12,wherein the first and third regions are disposed in a region of thedisplay and the region of the first and third regions is randomlyselected.
 15. The method recited in claim 1, wherein the first contrastlevel of the second color is the same as the second contrast level ofthe second color.
 16. The method recited in claim 1, wherein the firstcontrast level of the second color is different from the second contrastlevel of the second color.
 17. A method for administering a conecontrast color vision test to a patient using a computer, comprising thesteps of: (a) displaying a first display screen simultaneouslydisplaying at least a first color and a second color in at least tworegions of the display, the first color being displayed at a firstcontrast level and the second color being displayed at a second contrastlevel, the display screen being in communication with the computer; (b)receiving an input signal from the patient via an input device incommunication with the computer, where the input signal is indicative ofwhether the patient recognizes one or more of the first and secondcolor; (c) displaying a second display screen simultaneously displayingat least the first color and the second color in the at least tworegions at third and a fourth contrast levels, respectively; and (d)receiving a second input signal from the patient via the input device,where the second input signal is indicative of whether the patientrecognizes the one or more of the first and second color; and, (e)assigning a score to the first and second input signals, the scorerelated to a cone sensitivity of the patient to the first and secondcolors.
 18. The method recited in claim 17, wherein the first and secondcolor are the same.
 19. The method of claim 17, wherein at least one ofthe first and second color are different.
 20. The method of claim 19,wherein the at least one of the second color is grey. 21.-28. (canceled)